Urinary Bladder, Overactive Clinical Trial
— VENUSOfficial title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder
Verified date | September 2014 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.
Status | Completed |
Enrollment | 739 |
Est. completion date | September 2005 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB - Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study. - Patients having urgency with or without urge incontinence accompanied by frequency of =8 episodes per 24 hours, and/or nocturia, for a period of =3 months prior to screening. Exclusion Criteria: - Previous treatment with darifenacin - Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months - Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator - Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones - Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
United States,
Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8. — View Citation
Toglia MR, Serels SR, Laramée C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome | Weeks 1, 4, 8 and 12 | No | |
Secondary | Improvement of urgency | Weeks 1, 4, 8 and 12 | No | |
Secondary | Improvement of frequency, incontinence and nocturia | Weeks 1, 4, 8 and 12 | No | |
Secondary | Number of patients satisfied with treatment | Weeks 1, 4, 8 and 12 | No | |
Secondary | Assessment of the efficacy | End of study | No | |
Secondary | Evaluation of the safety and tolerability | Baseline to end of study | No |
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