A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.

Study Overview
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Brief Summary
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Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy. Secondary Objectives: To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. . To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .

Official Title
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A Prospective, Multi-center, Placebo-controlled, Randomized, Double-blind, Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo Administered as Oral Daily Dose for Three Months in Patients Suffering From Overactive Bladder.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Tarafenacin 0.2 mg
* Drug: Placebo
* Drug: Tarafenacin 0.4 mg


Participation Criteria
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Eligibility Criteria
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< Inclusion Criteria> Patient of either sex aged 20 to 80 years (both inclusive); Patients suffering from Overactive Bladder. based on cardinal symptoms (urgency, nocturia, frequency with or without urge incontinence) for at least 6 months prior to inclusion; Patients who document the following symptoms in a 3-day diary card during the 14 day placebo run-in period An average of ≥8 micturitions/24 hours; Greater than or equal to three incontinence episodes A total of ≥3 urgency episodes. <Exclusion Criteria> Patients with Clinically significant bladder outlet obstruction Patients with predominant stress incontinence (>2 episode/week) Patients with significant urogenital disease such as recurrent urinary tract infection (more than 2/6 months), bladder calculi, interstitial cystitis, urothelial tumours, hysterectomy or prostatectomy in the previous six months; Females diagnosed with bladder cancer Males diagnosed with bladder cancer Patients with obstructive disease of the gastrointestinal tract, intestinal inflammatory disease, severe ulcerative colitis, inflammatory bowel disease, toxic megacolon, intestinal atony or paralytic ileum Patients with acute Noehyeolgwangye disease, significant Cardiovascular Disease (arrhythmias, unstable angina pectoris, myocardial infarct, or are using a pacemaker), significant Orthostatic hypotension in the previous six months Patients diagnosed with closed angle glaucoma or shallowness of the anterior chamber Patients with any contraindication to antimuscarinic drugs

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tarafenacin 0.2 mg<br>Group 1 | Drug: Tarafenacin 0.2 mg<br>* Capsule, qd, 12 weeks<br>|
| Experimental: Tarafenacin 0.4 mg<br>Group 2 | Drug: Tarafenacin 0.4 mg<br>* Capsule, qd, 12 weeks<br>|
| Placebo Comparator: Placebo<br>Group 3 | Drug: Placebo<br>* Capsule, qd, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to 12weeks in Number of urgency episodes |  | 12 weeks | 
| Mean change from baseline to 12weeks in Number of incontinence episodes |  | 12 weeks | 
| Mean change from baseline to 12weeks in Number of nocturia episodes |  | 12weeks | 
| Mean change from baseline to 12weeks in Volume of urine passed per void |  | 12weeks | 
| Mean change from baseline to 12weeks in score of King's Health Questionnaire |  | 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Tarafenacin