Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR) (VECTOR)
|ClinicalTrials.gov Identifier: NCT00431041|
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : January 11, 2010
Last Update Posted : June 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: solifenacin Drug: oxybutynin immediate release||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|