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OpenTrials
Completed

NCT Number: 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.

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. .

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

< 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

Treatment and study plan

Tarafenacin 0.2 mg

Drug

Capsule, qd, 12 weeks

Placebo

Drug

Capsule, qd, 12 weeks

Tarafenacin 0.4 mg

Drug

Capsule, qd, 12 weeks

Primary outcomes

  1. the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period

    Time frame: 12 weeks

Secondary outcomes

  1. Mean change from baseline to 12weeks in Number of urgency episodes

    Time frame: 12 weeks

  2. Mean change from baseline to 12weeks in Number of incontinence episodes

    Time frame: 12 weeks

  3. Mean change from baseline to 12weeks in Number of nocturia episodes

    Time frame: 12weeks

  4. Mean change from baseline to 12weeks in Volume of urine passed per void

    Time frame: 12weeks

  5. Mean change from baseline to 12weeks in score of King's Health Questionnaire

    Time frame: 12weeks

Sponsors and collaborators

Lead sponsor

Kwang Dong Pharmaceutical co., ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 24, 2011
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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