Status:
COMPLETED
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.
Lead Sponsor:
Kwang Dong Pharmaceutical co., ltd.
Conditions:
Overactive Bladder
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
1. Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy. 2. Secondary Objectives: * To compare 12 weeks' efficacy of different doses of tarafenacin to that ...
Eligibility Criteria
Inclusion
- \< 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT01458197
Start Date
September 1 2011
End Date
November 1 2012
Last Update
March 12 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736