Clinical trial NCT01458197: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Tarafenacin
Lead sponsor: Kwang Dong Pharmaceutical co., ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 235
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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. .


Eligibility criteria: \< Inclusion Criteria\>

1. Patient of either sex aged 20 to 80 years (both inclusive);
2. 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;
3. 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\>

1. Patients with Clinically significant bladder outlet obstruction
2. Patients with predominant stress incontinence (\>2 episode/week)
3. 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;
4. Females diagnosed with bladder cancer
5. Males diagnosed with bladder cancer
6. Patients with obstructive disease of the gastrointestinal tract, intestinal inflammatory disease, severe ulcerative colitis, inflammatory bowel disease, toxic megacolon, intestinal atony or paralytic ileum
7. 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
8. Patients diagnosed with closed angle glaucoma or shallowness of the anterior chamber
9. Patients with any contraindication to antimuscarinic drugs

Primary outcomes:
measure: the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean change from baseline to 12weeks in Number of urgency episodes
timeFrame: 12 weeks
measure: Mean change from baseline to 12weeks in Number of incontinence episodes
timeFrame: 12 weeks
measure: Mean change from baseline to 12weeks in Number of nocturia episodes
timeFrame: 12weeks
measure: Mean change from baseline to 12weeks in Volume of urine passed per void
timeFrame: 12weeks
measure: Mean change from baseline to 12weeks in score of King's Health Questionnaire
timeFrame: 12weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Myung-Soo Choo, Professor
role: PRINCIPAL_INVESTIGATOR
References: