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OpenTrials
Completed

NCT Number: NCT00212706

Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

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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 Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are 20 years old or over with overactive bladder
  • Total number of urinary incontinence episodes per week is 5 or over
  • Mean number of micturition per day is 8 or over
  • Mean number of urinary urgency episodes per day is 1 or over
  • Other inclusion criteria as specified in the study protocol

Exclusion criteria

  • Patients with genuine stress incontinence
  • Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
  • Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
  • Patients suffering from complications for which anticholinergics are contraindicated
  • Other exclusion criteria as specified in the study protocol

Treatment and study plan

ONO-8025 (KRP-197)

Drug

Primary outcomes

  1. Total number of urinary incontinence episodes per week

Secondary outcomes

  1. Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2001
Primary completion
2002
First posted
Sep 21, 2005
Registry last updated
Oct 12, 2012

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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