NCT00431041: VECTOR

VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients

Completed Phase 4 Results posted Last updated 1 June 2010

What this trial tests

Phase 4 trial testing solifenacin in Overactive Bladder in 132 participants. Completed in 1 February 2008.

Timeline

1 December 2006

Primary endpoint
1 February 2008

1 February 2008

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	132
Start date	1 December 2006
Primary completion	1 February 2008
Estimated completion	1 February 2008
Sites	12 locations across Canada

Drugs / interventions tested

• solifenacin (SOLIFENACIN) — full drug profile →
• oxybutynin immediate release — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (≤ 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study.
   Herschorn S, Pommerville P, Stothers L, Egerdie B, et al · · 2011 · cited 17× · PMID 21175373 · DOI 10.1185/03007995.2010.541433
2. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder.
   Herschorn S, Vicente C, Piwko C. · · 2010 · cited 10× · PMID 20690893 · DOI 10.3111/13696998.2010.509244
3. A Computational Text Mining-Guided Meta-Analysis Approach to Identify Potential Xerostomia Drug Targets.
   Beckman MF, Brennan EJ, Igba CK, Brennan MT, et al · · 2022 · cited 4× · PMID 35268532 · DOI 10.3390/jcm11051442
4. Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database.
   Chapple CR, Cardozo L, Snijder R, Siddiqui E, et al · · 2016 · cited 2× · PMID 29736483 · DOI 10.1016/j.conctc.2016.10.003