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.

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458197
• Other study ID #: TFN-KD01
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2011
• Last updated: March 11, 2014
• Start date: September 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2014
• Source: Kwang Dong Pharmaceutical co., ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

< 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 Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Tarafenacin 0.2 mg
Capsule, qd, 12 weeks
• Placebo
Capsule, qd, 12 weeks
• Tarafenacin 0.4 mg
Capsule, qd, 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kwang Dong Pharmaceutical co., ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period		12 weeks	No
Secondary	Mean change from baseline to 12weeks in Number of urgency episodes		12 weeks	No
Secondary	Mean change from baseline to 12weeks in Number of incontinence episodes		12 weeks	No
Secondary	Mean change from baseline to 12weeks in Number of nocturia episodes		12weeks	No
Secondary	Mean change from baseline to 12weeks in Volume of urine passed per void		12weeks	No
Secondary	Mean change from baseline to 12weeks in score of King's Health Questionnaire		12weeks	No