Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR) (VECTOR)
|Overactive Bladder||Drug: solifenacin Drug: oxybutynin immediate release||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]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 ]
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 ]
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 ]
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.
|Study Start Date:||December 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Solifenacin succinate: 5 mg tablets, taken orally, once daily
Active Comparator: Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
Drug: oxybutynin immediate release
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431041
|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|
|Guelph, Ontario, Canada, N1H 5J1|
|Kitchener, Ontario, Canada, N2N 2B9|
|Toronto, Ontario, Canada, M4N 3M5|
|Toronto, Ontario, Canada, M5G 1Z5|
|Toronto, Ontario, Canada, M5T 2S8|
|Toronto, Ontario, Canada, M6A 3B5|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Director:||Use Central Contact||Astellas Pharma Canada, Inc.|