Status:
COMPLETED
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered whe...
Eligibility Criteria
Inclusion
- Women \> 18 years Old
- Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week)
Exclusion
- Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
- Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
- Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00746681
Start Date
December 1 2005
End Date
November 1 2006
Last Update
December 21 2009
Active Locations (23)
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1
Pfizer Investigational Site
Hradec Králové, Czechia, 500 05
2
Pfizer Investigational Site
Prague, Czechia, 110 00
3
Pfizer Investigational Site
Prague, Czechia, 130 00
4
Pfizer Investigational Site
Praha 4 - Krc, Czechia, 140 59