FindTrial
Sign In

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01458197
Enrollment
235
Registered
2011-10-24
Start date
2011-09-30
Completion date
2012-11-30
Last updated
2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Overactive Bladder, Tarafenacin

Brief 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. .

Interventions

DRUGTarafenacin 0.2 mg

Capsule, qd, 12 weeks

DRUGPlacebo

Capsule, qd, 12 weeks

DRUGTarafenacin 0.4 mg

Capsule, qd, 12 weeks

Sponsors

Kwang Dong Pharmaceutical co., ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion 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 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

Design outcomes

Primary

MeasureTime frame
the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period12 weeks

Secondary

MeasureTime frame
Mean change from baseline to 12weeks in Number of urgency episodes12 weeks
Mean change from baseline to 12weeks in Number of incontinence episodes12 weeks
Mean change from baseline to 12weeks in Number of nocturia episodes12weeks
Mean change from baseline to 12weeks in Volume of urine passed per void12weeks
Mean change from baseline to 12weeks in score of King's Health Questionnaire12weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026