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.

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. .

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Tarafenacin 0.2 mg; Drug: Tarafenacin 0.4 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

< 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline to 12weeks in Number of urgency episodes	12 weeks
Mean change from baseline to 12weeks in Number of incontinence episodes	12 weeks
Mean change from baseline to 12weeks in Number of nocturia episodes	12weeks
Mean change from baseline to 12weeks in Volume of urine passed per void	12weeks
Mean change from baseline to 12weeks in score of King's Health Questionnaire	12weeks

Collaborators and Investigators

• Sponsor: Kwang Dong Pharmaceutical co., ltd.
• Investigators: Principal Investigator: Myung-Soo Choo, Professor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 11, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Overactive Bladder; Tarafenacin
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: TFN-KD01