A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

Study Overview
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Brief Summary
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This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

Official Title
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A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: tolterodine tartrate
* Drug: Comparator: Placebo to tolterodine tartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a postmenopausal female 40 to 75 years of age Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2 Patient has a documented history of overactive bladder for at least 6 months prior to screening Exclusion Criteria: Patient has stress or mixed incontinence Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain Patient has a history of stroke, seizures, or major neurological disorders Patient has a history of fecal incontinence Patient has a history of continual urine leakage Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start Patient received bladder training of electrostimulation within 2 weeks of study start Patient requires a catheter Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start Patient has been on hormone replacement therapy for less than 12 weeks at study start Patient must take medication for arrhythmia Patient consumes more than 2 alcoholic beverages per day Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine) Patient has multiple and/or severe allergies to foods and drugs Patient regularly uses any illegal drugs

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo | Drug: tolterodine tartrate<br>* Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule<br>Drug: Comparator: Placebo to tolterodine tartrate<br>* Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule<br>|
| Experimental: 2<br>Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd) | Drug: tolterodine tartrate<br>* Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule<br>Drug: Comparator: Placebo to tolterodine tartrate<br>* Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule<br>|
| Experimental: 3<br>Part II, Sequence 1: study drug crossing over to placebo | Drug: tolterodine tartrate<br>* Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule<br>Drug: Comparator: Placebo to tolterodine tartrate<br>* Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule<br>|
| Experimental: 4<br>Part II, Sequence 2: placebo crossing over to study drug | Drug: tolterodine tartrate<br>* Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule<br>Drug: Comparator: Placebo to tolterodine tartrate<br>* Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo | Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data) | 4 hours post dose 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo | Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data) | 4 hours post dose 1 |