Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Tolterodine & Pregabalin
* Drug: Tolterodine
* Drug: Placebo
* Drug: Tolterodine & Pregabalin
* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily | Drug: Tolterodine & Pregabalin<br>* Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks<br>|
| Active Comparator: B<br>Tolterodine SR 4 mg once daily | Drug: Tolterodine<br>* Tolterodine SR, Oral, 4 mg, once daily for 4 weeks<br>|
| Placebo Comparator: C<br>Placebo | Drug: Placebo<br>* Placebo, Oral, twice daily for 4 weeks<br>|
| Experimental: D<br>Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily | Drug: Tolterodine & Pregabalin<br>* Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks<br>|
| Experimental: E<br>Pregabalin 150 mg twice daily | Drug: Pregabalin<br>* Pregabalin, Oral, 150 mg twice daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean voided volume per micturition (from baseline). |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline). |  | 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 Health Related Quality of Life (using the OAB-q SF HRQL scale) |  | 4 Weeks | 
| Patient Perception of Bladder Condition (PPBC) scale |  | 4 Weeks |