Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: solifenacin Drug: oxybutynin immediate release |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients |
- The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
- The Severity of Dry Mouth Reported as an Adverse Event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).
Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) & "severe" (very dry mouth & throat, difficulty swallowing solid food without water)
- Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.
The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline.
- Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.
The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline.
| Enrollment: | 132 |
| Study Start Date: | December 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Solifenacin
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Drug: solifenacin
Oral
Other Names:
|
|
Active Comparator: Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
Drug: oxybutynin immediate release
Oral
|
Detailed Description:
This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults 18 years and older.
- Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)
Exclusion Criteria:
- Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction
- Uncontrolled narrow angle glaucoma, urinary, or gastric retention
- Severe renal or hepatic impairment
- Chronic severe constipation or history of diagnosed GI obstructive disease
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Diagnosis or history of neurogenic bladder
- History of bladder or pelvic cancer
Contacts and Locations| Canada, Alberta | |
| Calgary, Alberta, Canada, T2V 4R6 | |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Victoria, British Columbia, Canada, V8T 5G1 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Guelph, Ontario, Canada, N1H 5J1 | |
| Kitchener, Ontario, Canada, N2N 2B9 | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Toronto, Ontario, Canada, M5G 1Z5 | |
| Toronto, Ontario, Canada, M6A 3B5 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Study Director: | Use Central Contact | Astellas Pharma Canada, Inc. |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc |
| ClinicalTrials.gov Identifier: | NCT00431041 History of Changes |
| Other Study ID Numbers: | VES-001 |
| Study First Received: | February 1, 2007 |
| Results First Received: | October 5, 2009 |
| Last Updated: | June 1, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Astellas Pharma Inc:
|
Solifenacin succinate Oxybutynin immediate release Xerostomia Overactive bladder |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Oxybutynin Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013