The PHASE II STUDY TO COMPARE THE EFFICACY AND TOLERABILITY OF TARAFENACIN 0.2 MG AND TARAFENACIN 0.4 MG TO PLACEBO ADMINISTERED IN PATIENTS SUFFERING FROM OVERACTIVE BLADDER

A PROSPECTIVE, MULTI-CENTRE, PLACEBO CONTROLLED, RANDOMIZED, DOUBLE BLIND, PHASE II 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

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000207

Enrollment

240

Registered

2011-10-20

Start date

2011-09-26

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : 1. IP : Tarafenacin 0.2mg / Tarafenacin 0.4mg / Placebo 2. design : This will be a multicentre, parallel-design, placebo and active-treatment controlled, randomised, double-blind study in pati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient of either sex aged 20 to 80 years (both inclusive); 2. Patients suffering from OAB 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Mean change from baseline to 12weeks in Number of urgency episodes ;Mean change from baseline to 12weeks in Number of incontinence episodes;Mean change from baseline to 12weeks in Number of nocturia episodes;Mean change from baseline to 12weeks in Volume of urine passed per void;Mean change from baseline to 12weeks in score of King’s Health Questionnaire	—

Countries

Korea, Republic of

Contacts

Public ContactYoung-Mi Song

Kwang Dong Pharmaceutical

Outcome results