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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.

This study is currently recruiting participants.
Verified October 2011 by Kwang Dong Pharmaceutical co., ltd.
Sponsor:
Information provided by (Responsible Party):
Kwang Dong Pharmaceutical co., ltd.
ClinicalTrials.gov Identifier:
NCT01458197
First received: October 19, 2011
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

  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. .

Condition Intervention Phase
Overactive Bladder
 Drug: Tarafenacin 0.2 mg
Drug: Placebo
Drug: Tarafenacin 0.4 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kwang Dong Pharmaceutical co., ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline to 12weeks in Number of urgency episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12weeks in Number of incontinence episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12weeks in Number of nocturia episodes [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12weeks in Volume of urine passed per void [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12weeks in score of King's Health Questionnaire [ Time Frame: 12weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 234
Study Start Date: September 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tarafenacin 0.2 mg
Group 1
 Drug: Tarafenacin 0.2 mg
Capsule, qd, 12 weeks
Experimental: Tarafenacin 0.4 mg
Group 2
 Drug: Tarafenacin 0.4 mg
Capsule, qd, 12 weeks
Placebo Comparator: Placebo
Group 3
 Drug: Placebo
Capsule, qd, 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 obstrucion
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458197

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: MS Choo         mschoo@amc.seoul.kr    
Sponsors and Collaborators
Kwang Dong Pharmaceutical co., ltd.
  More Information

No publications provided

Responsible Party: Kwang Dong Pharmaceutical co., ltd.
ClinicalTrials.gov Identifier: NCT01458197     History of Changes
Other Study ID Numbers: TFN-KD01
Study First Received: October 19, 2011
Last Updated: October 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kwang Dong Pharmaceutical co., ltd.:
Overactive Bladder
Tarafenacin

Additional relevant MeSH terms:
Stress, Psychological
Urinary Bladder, Overactive
Behavioral Symptoms
Urinary Bladder Diseases
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013