Trial | NCT01458197  Report issue

Title

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.
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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tarafenacin ...

  • Study Participants

    235
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. .
Study Started
Sep 30
2011
Primary Completion
Aug 31
2012
Study Completion
Nov 30
2012
Last Update
Mar 12
2014
Estimate

Drug Tarafenacin 0.2 mg

Capsule, qd, 12 weeks

Drug Placebo

Capsule, qd, 12 weeks

Drug Tarafenacin 0.4 mg

Capsule, qd, 12 weeks

Tarafenacin 0.2 mg Experimental

Group 1

Tarafenacin 0.4 mg Experimental

Group 2

Placebo Placebo Comparator

Group 3

Criteria 

< 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
No Results Posted