A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

Overview

To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.

Full Title of Study: “A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • Drug: KUC-7483
  • Drug: Placebo
  • Drug: Tolterodine

Arms, Groups and Cohorts

  • Experimental: KUC-7483
  • Placebo Comparator: Placebo
  • Active Comparator: Tolterodine

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in the mean number of micturitions per 24 hours
    • Time Frame: 12 weeks

Secondary Measures

  • Change from baseline in the mean number of urgency episodes per 24 hours
    • Time Frame: 12 weeks
  • Change from baseline in the mean number of incontinence episodes per 24 hours
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with a symptom of overactive bladder for more than 6 months. – Patients who meet the following condition during the 3-day bladder diary period. – the mean number of micturitions per 24 hours is ≥8 times – the mean number of urgency episodes per 24 hours is ≥1 time Exclusion Criteria:

  • Patients who are diagnosed as stress urinary incontinence are predominant. – Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kissei Pharmaceutical Co., Ltd.
  • Overall Official(s)
    • Yasuhiro Omori, Study Director, Clinical Development Department, Kissei pharmaceutical Co., Ltd.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.