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A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00404391
First received: November 26, 2006
Last updated: January 14, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.


Condition Intervention Phase
Pain
 Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Pain relief measured by a 100mm Visual Analog Scale (VAS)


Secondary Outcome Measures:
  • Time interval weighted sum of pain intensity difference (SPID)scores [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Sum of pain intensity difference


Enrollment: 210
Study Start Date: October 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: hydrocodone/acetaminophen extended release Drug: Hydrocodone/Acetaminophen Extended Release
1 tablet every 12 hours
Other Names:
  • ABT-712
  • hydrocodone/acetaminophen extended release
Experimental: Arm 2: hydrocodone/acetaminophen extended release Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets every 12 hours
Other Names:
  • ABT-712
  • hydrocodone/acetaminophen extended release
Placebo Comparator: placebo Drug: Placebo
2 tablets every 12 hours
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ages 18 to 65
  • Females must be of non-childbearing potential or practicing birth control
  • Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

Exclusion Criteria:

  • Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
  • Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
  • Is associated with any currently ongoing research study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404391

Locations
United States, Maryland
Site Ref # / Investigator 4993
Owing Mills, Maryland, United States, 21117
United States, Texas
Site Ref # / Investigator 4994
Austin, Texas, United States, 78705
Site Ref # / Investigator 4992
San Marcos, Texas, United States, 78666
United States, Utah
Site Ref # / Investigator 4995
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rita Jain, MD Abbott
  More Information

No publications provided

Responsible Party: Victor Jorden, MD, Abbott
ClinicalTrials.gov Identifier: NCT00404391     History of Changes
Other Study ID Numbers: M03-609
Study First Received: November 26, 2006
Last Updated: January 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Moderate to severe pain following bunionectomy surgery

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Hydrocodone
Oxycodone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013