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OpenTrials
Completed

NCT Number: NCT01004315

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

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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Japan

Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KUC-7483

Drug

Placebo

Drug

tolterodine

Drug

Primary outcomes

  1. Change from baseline in the mean number of micturitions per 24 hours

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in the mean number of urgency episodes per 24 hours

    Time frame: 12 weeks

  2. Change from baseline in the mean number of incontinence episodes per 24 hours

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder

Important dates

First posted
Oct 29, 2009
Registry last updated
Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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