Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01057693
First received: January 26, 2010
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Neuropathy, Painful |
Drug: pregabalin (Lyrica) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3b Multicenter, Double-Blind, Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase [ Time Frame: SB Baseline, Week 19 (DB Phase) ] [ Designated as safety issue: No ]Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Secondary Outcome Measures:
- Time to Loss of Pain Response (Double-Blind Phase) [ Time Frame: SB Baseline up to Week 19 ] [ Designated as safety issue: No ]Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase [ Time Frame: SB Baseline, Week 6 (SB Phase) ] [ Designated as safety issue: No ]Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Weekly Mean Pain Scores (Single-Blind Phase) [ Time Frame: Week 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.
- Weekly Mean Pain Scores (Double-Blind Phase) [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ] [ Designated as safety issue: No ]Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.
- Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.
- Patient Global Impression of Change (PGIC) (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
- Patient Global Impression of Change (PGIC) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
- Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
- Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
- Weekly Mean Sleep Interference Score (Single-Blind Phase) [ Time Frame: SB Baseline, Week 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Weekly Mean Sleep Interference Score (Double-Blind Phase) [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ] [ Designated as safety issue: No ]Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).
- Endpoint Mean Sleep Interference Score (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
- Endpoint Mean Sleep Interference Score (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
- Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
- Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
- Pain Visual Analog Scale (VAS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
- Pain Visual Analog Scale (VAS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
- Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
- Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
- Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
- Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
- Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
- Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
| Enrollment: | 665 |
| Study Start Date: | March 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: pregabalin (Lyrica) |
Drug: pregabalin (Lyrica)
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
Other Name: pregabalin (Lyrica)
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo is supplied as capsules and given 3 times daily.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
Exclusion Criteria:
- Patients with other pain conditions cannot participate.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057693
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| United States, Alabama | |
| Greystone Medical Research, LLC | |
| Birmingham, Alabama, United States, 35242 | |
| Neurology Clinic, PC | |
| Northport, Alabama, United States, 35476 | |
| United States, Arizona | |
| Horizon Clinical Research Associates, PLLC | |
| Gilbert, Arizona, United States, 85295 | |
| Dedicated Clinical Research, Inc. | |
| Goodyear, Arizona, United States, 85395 | |
| Dedicated Clinical Research | |
| Goodyear, Arizona, United States, 85395 | |
| Novara Clinical Research | |
| Mesa, Arizona, United States, 85206 | |
| Arizona Research Center | |
| Phoenix, Arizona, United States, 85023 | |
| Radiant Research, Inc. | |
| Scottsdale, Arizona, United States, 85251 | |
| Genova Clinical Research, Inc. | |
| Tucson, Arizona, United States, 85704 | |
| United States, Arkansas | |
| Central Arkansas Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| Little Rock Diagnostic Clinic | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Convergys Clinical Research, Inc. | |
| Anaheim, California, United States, 92805 | |
| Providence Clinical Research | |
| Burbank, California, United States, 91505 | |
| Valley Research | |
| Fresno, California, United States, 93720 | |
| Center for United Research, Inc. | |
| Lakewood, California, United States, 90712 | |
| Healthcare Partners Medical Group | |
| Los Angeles, California, United States, 90015 | |
| University of Southern California, Keck School of Medicine, Department of Neurology | |
| Los Angeles, California, United States, 90033 | |
| Richard S. Cherlin, MD | |
| Los Gatos, California, United States, 95032 | |
| Northridge Neurological Research | |
| Northridge, California, United States, 91325 | |
| Remek Research | |
| Pomona, California, United States, 91767 | |
| Sierra Clinical Research | |
| Roseville, California, United States, 95661 | |
| CNRI-San Diego, LLC | |
| San Diego, California, United States, 92102 | |
| San Diego Clinical Trials | |
| San Diego, California, United States, 92120 | |
| Center for Clinical Research, Inc. | |
| San Francisco, California, United States, 94115 | |
| Apex Research Institute | |
| Santa Ana, California, United States, 92705 | |
| Neurological Research Institute | |
| Santa Monica, California, United States, 90404 | |
| Diablo Clinical Research, Inc. | |
| Walnut Creek, California, United States, 94598 | |
| Foothills Pain Management | |
| West Covina, California, United States, 91790 | |
| United States, Colorado | |
| Aurora Family Medicine Center, PC | |
| Aurora, Colorado, United States, 80012 | |
| Alpine Clinical Research Center, Inc. | |
| Boulder, Colorado, United States, 80304 | |
| Mountain View Clinical Research | |
| Denver, Colorado, United States, 80209 | |
| United States, Connecticut | |
| Chase Medical Research, LLC | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Metabolic Research Institute, Inc. | |
| Boynton Beach, Florida, United States, 33472 | |
| Meridien Research | |
| Bradenton, Florida, United States, 34208 | |
| Bradenton Research Center | |
| Bradenton, Florida, United States, 34205 | |
| Meridien Research | |
| Brooksville, Florida, United States, 34601 | |
| Innovative Research of West Florida, Inc. | |
| Clearwater, Florida, United States, 33756 | |
| Clinical Research of West Florida, Inc. | |
| Clearwater, Florida, United States, 33765 | |
| Deerfield Beach Cardiology Research | |
| Deerfield Beach, Florida, United States, 33442 | |
| Gulfcoast Clinical Research Center | |
| Ft. Myers, Florida, United States, 33912 | |
| MD Clinical | |
| Hallandale Beach, Florida, United States, 33009 | |
| Elite Research Institute | |
| Miami, Florida, United States, 33169 | |
| Suncoast Clinical Research, Inc. | |
| New Port Richey, Florida, United States, 34652 | |
| Laszlo J. Mate, MD | |
| North Palm Beach, Florida, United States, 33408 | |
| Family Care Specialists, Inc. | |
| Ocala, Florida, United States, 34471 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Compass Research, LLC | |
| Orlando, Florida, United States, 32806 | |
| Palm Beach Neurological Center, Advanced Research Consultants, Inc. | |
| Palm Beach Gardens, Florida, United States, 33418 | |
| Drug Shipment Address: | |
| Palm Harbor, Florida, United States, 34684 | |
| Suncoast Clinical Research | |
| Palm Harbor, Florida, United States, 34684 | |
| Meridien Research | |
| St. Petersburg, Florida, United States, 33709 | |
| Neurology Clinical Research, Inc. | |
| Sunrise, Florida, United States, 33351 | |
| Clinical Research of West Florida, Inc. | |
| Tampa, Florida, United States, 33603 | |
| Meridien Research | |
| Tampa, Florida, United States, 33606 | |
| Clinical Research of Central Florida | |
| Winter Haven, Florida, United States, 33880 | |
| United States, Georgia | |
| NeuroTrials Research, Incorporated | |
| Atlanta, Georgia, United States, 30342 | |
| CPM Research Institute | |
| Austell, Georgia, United States, 30106 | |
| Columbus Research Foundation | |
| Columbus, Georgia, United States, 31904 | |
| Rockdale Medical Research Associates | |
| Conyers, Georgia, United States, 30094 | |
| Valley Health Care | |
| Rome, Georgia, United States, 30165 | |
| Prism Research Group | |
| Rome, Georgia, United States, 30165 | |
| United States, Hawaii | |
| East-West Medical Research Institute | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Idaho | |
| Advanced Clinical Research | |
| Meridian, Idaho, United States, 83642 | |
| United States, Illinois | |
| AMR Sakeena Research | |
| Aurora, Illinois, United States, 60504 | |
| Chicago Research Center, Inc. | |
| Chicago, Illinois, United States, 60634 | |
| American Medical Research, Inc. | |
| Oak Brook, Illinois, United States, 60523 | |
| United States, Indiana | |
| MediSphere Medical Research Center, LLC | |
| Evansville, Indiana, United States, 47714 | |
| American Health Network | |
| Greenfield, Indiana, United States, 46140 | |
| Rehabilitation Associates of Indiana | |
| Indianapolis, Indiana, United States, 46250 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Heartland Research Associates, LLC | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Kentucky Medical Research Center | |
| Lexington, Kentucky, United States, 40504 | |
| United States, Louisiana | |
| Primary Physician Care, LLC | |
| Lake Charles, Louisiana, United States, 70601 | |
| Heartland Research, LLC | |
| Lake Charles, Louisiana, United States, 70601 | |
| Endocrinology Center of Southwest Louisiana | |
| Lake Charles, Louisiana, United States, 70601 | |
| Arthritis and Diabetes Clinic, Inc | |
| Monroe, Louisiana, United States, 71203 | |
| United States, Massachusetts | |
| Miray Medical Center | |
| Brockton, Massachusetts, United States, 02301 | |
| Clinical Research Center of Cape Cod, Inc. | |
| Hyannis, Massachusetts, United States, 02601 | |
| MedVadis Research Corporation | |
| WaterTown, Massachusetts, United States, 02472 | |
| Clinical Pharmacology Study Group | |
| Worcester, Massachusetts, United States, 01610 | |
| United States, Michigan | |
| Michigan Head Pain and Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| Harris and Associates MD, PC | |
| Detroit, Michigan, United States, 48235 | |
| Borgess Research Institute | |
| Kalamazoo, Michigan, United States, 49048 | |
| Borgess Diabetes Center | |
| Kalamazoo, Michigan, United States, 49048 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| KMED Research | |
| St. Clair Shores, Michigan, United States, 48081 | |
| William Beaumont Hospital | |
| Troy, Michigan, United States, 48085 | |
| Troy Internal Medicine, PC | |
| Troy, Michigan, United States, 48098 | |
| United States, Minnesota | |
| Medical Advanced Pain Specialists (MAPS) | |
| Edina, Minnesota, United States, 55435 | |
| MAPS Applied Research Center, Inc. | |
| Edina, Minnesota, United States, 55435 | |
| Medical Advanced Pain Specialists | |
| Maple Grove, Minnesota, United States, 55369 | |
| Medical Advanced Pain Specialists | |
| Shakopee, Minnesota, United States, 55379 | |
| United States, Mississippi | |
| Physician's Surgery Center | |
| Jackson, Mississippi, United States, 39202 | |
| CRC of Jackson | |
| Jackson, Mississippi, United States, 39202 | |
| Randall T. Huling, Jr., MD, CPI | |
| Olive Branch, Mississippi, United States, 38654 | |
| United States, Missouri | |
| University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center | |
| Columbia, Missouri, United States, 65212 | |
| Melinda A. Crockett-Maples | |
| Marionville, Missouri, United States, 65705 | |
| Clinvest | |
| Springfield, Missouri, United States, 65807 | |
| A & A Pain Institute of Saint Louis | |
| St Louis, Missouri, United States, 63141 | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Lincoln Internal Medicine Associates | |
| Lincoln, Nebraska, United States, 68516 | |
| United States, Nevada | |
| Desert Endocrinology Clinical Research Center | |
| Henderson, Nevada, United States, 89052 | |
| Desert Endocrinology | |
| Las Vegas, Nevada, United States, 89117 | |
| Office of Dr. Danka Michaels, MD | |
| Las Vegas, Nevada, United States, 89128 | |
| Office of Stephen Miller, M.D. | |
| Las Vegas, Nevada, United States, 89144 | |
| United States, North Carolina | |
| Raleigh Neurology Associates, P.A. | |
| Raleigh, North Carolina, United States, 27607-6520 | |
| Carolina Pharmaceutical Research | |
| Statesville, North Carolina, United States, 28625 | |
| United States, Ohio | |
| Radiant Research, Inc. | |
| Akron, Ohio, United States, 44311 | |
| Community Research | |
| Cincinnati, Ohio, United States, 45245 | |
| Radiant Research | |
| Cincinnati, Ohio, United States, 45249 | |
| Providence Health Partners - Center for Clinical Research | |
| Dayton, Ohio, United States, 45439 | |
| Hometown Urgent Care and Research | |
| Dayton, Ohio, United States, 45432 | |
| United States, Oklahoma | |
| Sooner Clinical Research | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Angelique Barreto, MD | |
| Oklahoma City, Oklahoma, United States, 73134 | |
| Veronique Sebastian, MD | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Study drug shipments should be sent to: | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Blair Orthopedic Associates, Inc. | |
| Altoona, Pennsylvania, United States, 16602 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Research Protocol Management Specialists | |
| Pittsburg, Pennsylvania, United States, 15243 | |
| United States, Rhode Island | |
| Coastal Medical | |
| East Greenwich, Rhode Island, United States, 02818 | |
| Memorial Hospital of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| Omega Medical Research | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| Aiken Center for Clinical Research | |
| Aiken, South Carolina, United States, 29801 | |
| TLM Medical Services, LLC | |
| Columbia, South Carolina, United States, 29204 | |
| Radiant Research Inc. | |
| Greer, South Carolina, United States, 29651 | |
| Neurology and Pain Clinic, LLC | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Tennessee | |
| University Diabetes & Endocrine Consultants | |
| Chattanooga, Tennessee, United States, 37403 | |
| SCRI Research Center | |
| Germantown, Tennessee, United States, 38138 | |
| Sarah Cannon Research Institute | |
| Jackson, Tennessee, United States, 38305 | |
| AM Diabetes & Endocrinology Center | |
| Memphis, Tennessee, United States, 38133 | |
| Memphis Internal Medicine | |
| Memphis, Tennessee, United States, 38138 | |
| United States, Texas | |
| ClinRx Research LLC | |
| Carrollton, Texas, United States, 75007 | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390-8858 | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Medical Group of Texas | |
| Ft. Worth, Texas, United States, 76104 | |
| The Nerve and Muscle Center of Texas | |
| Houston, Texas, United States, 77030 | |
| ClinRx Research, LLC | |
| Richardson, Texas, United States, 75080 | |
| Cetero Research - San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Paragon Research Center, LLC | |
| San Antonio, Texas, United States, 78205 | |
| Alamo Clinical Research | |
| San Antonio, Texas, United States, 78212 | |
| Pioneer Research Solutions, Inc | |
| Sugar Land, Texas, United States, 77479 | |
| United States, Utah | |
| L. Craig Larsen and Clark C. Larsen | |
| Murray, Utah, United States, 84107 | |
| Aspen Clinical Research | |
| Orem, Utah, United States, 84058 | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
| Wasatch Clinical Research | |
| Salt Lake City, Utah, United States, 84107 | |
| Daniel B. Vine, MD | |
| Salt Lake City, Utah, United States, 84107 | |
| Foot and Ankle Clinic | |
| West Jordan, Utah, United States, 84088 | |
| United States, Virginia | |
| Neurological Associates, Incorporated | |
| Henrico, Virginia, United States, 23226 | |
| National Clinical Research - Norfolk, Inc. | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Spokane Internal Medicine | |
| Spokane, Washington, United States, 99216 | |
| United States, Wisconsin | |
| Aurora Advanced Healthcare, Inc. | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N4Z6 | |
| Canada, Manitoba | |
| Winnipeg Regional Health Authority Sciences Centre Winnipeg | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Winnipeg Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Capital District Health Authority | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Capital District Health Authority, Division of Endocrinology | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| The Ottawa Hospital, Riverside Campus - Riverside Professional Building | |
| Ottawa, Ontario, Canada, K1H 1A2 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Puerto Rico | |
| Ponce School of Medicine & Health Sciences | |
| Ponce, Puerto Rico, 00716 | |
| Instituto de Endocrinologia Diabetes y Metabolismo | |
| Toa Baja, Puerto Rico, 00949 | |
| South Africa | |
| Bloemfontein Medi-Clinic | |
| Bloemfontein, Free State, South Africa, 9301 | |
| Dr Makan's Rooms | |
| Johannesburg, Gauteng, South Africa, 1827 | |
| Chris Hani Baragwanath Hospital | |
| Soweto, Gauteng, South Africa, 2013 | |
| Randles Road Medical Centre | |
| Durban, Kwa-Zulu Natal, South Africa, 4000 | |
| Chelmsford Medical Centre | |
| Durban, Kwazulu Natal, South Africa, 4001 | |
| Parklands Medical Centre | |
| Overport, Kwazulu Natal, South Africa, 4091 | |
| Dr Jeevren Reddy's Surgery | |
| Stanger, Kwazulu Natal, South Africa, 4450 | |
| Dot Shuttleworth Centre for Diabetes | |
| Durban, Overport, South Africa, 4091 | |
| Centre for Diabetes and Endocrinology | |
| Houghton, Johannesburg, South Africa, 2198 | |
| 102 Parklands Medical Centre | |
| Overport, Durban, South Africa, 4001 | |
| Dr's Sauermann and Meyer | |
| Polokwane, South Africa | |
| Diabetes Care Centre | |
| Pretoria, South Africa, 0001 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01057693 History of Changes |
| Other Study ID Numbers: | A0081242 |
| Study First Received: | January 26, 2010 |
| Results First Received: | January 18, 2013 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Diabetic peripheral neuropathy Lyrica pregabalin pain |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Pain Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Signs and Symptoms Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 21, 2013