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.

NCT01458197 | Completed Phase 2

• 1 other identifier: TFN-KD01
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

• 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. .

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Tarafenacin

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

Tarafenacin 0.2 mg

EXPERIMENTAL

Group 1

Drug: Tarafenacin 0.2 mg

Tarafenacin 0.4 mg

EXPERIMENTAL

Group 2

Drug: Tarafenacin 0.4 mg

Placebo

PLACEBO COMPARATOR

Group 3

Drug: Placebo

Interventions

Tarafenacin 0.2 mg DRUG

Capsule, qd, 12 weeks

Tarafenacin 0.2 mg

Placebo DRUG

Capsule, qd, 12 weeks

Placebo

Tarafenacin 0.4 mg DRUG

Capsule, qd, 12 weeks

Tarafenacin 0.4 mg

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of either sex aged 20 to 80 years (both inclusive);
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kwang Dong Pharmaceutical co., ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Myung-Soo Choo, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 24, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

KR (1)