Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
Phase 2
Completed
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT00746681
- Lead Sponsor
- Pfizer
- 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 when it is combined with tolterodine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 188
Inclusion Criteria
- Women > 18 years Old
- Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Tolterodine & Pregabalin Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily C Placebo Placebo D Tolterodine & Pregabalin Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily B Tolterodine Tolterodine SR 4 mg once daily E Pregabalin Pregabalin 150 mg twice daily
- Primary Outcome Measures
Name Time Method Change in mean voided volume per micturition (from baseline). 4 weeks
- Secondary Outcome Measures
Name Time Method Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline). 4 Weeks Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale) 4 Weeks Percentage and absolute change in urgency episode frequency 4 Weeks Mean severity of urgency episodes 4 Weeks Percentage and absolute change in micturition frequency 4 Weeks Percentage and absolute change in normalized micturition frequency (NMF) 4 Weeks Patient perception of their urinary urgency (using the OAB-q symptom severity scale) 4 Weeks Patient Perception of Bladder Condition (PPBC) scale 4 Weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Plymouth, United Kingdom