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OpenTrials
Completed

NCT Number: NCT00512785

Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.

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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 3

Primary location

Kanto Region, Kanto, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and Woman equal or > 20 years old
  • Patients with urgency, urinary frequency and urgency incontinence

Exclusion criteria

  • Patients with genuine stress incontinence
  • Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
  • Patients suffering from complications contraindicating the use of antimuscarinic medication
  • Patients with polyuria

Treatment and study plan

imidafenacin, KRP-197/ONO-8025

Drug

0.1 mg BID for 52 weeks

Primary outcomes

  1. Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume

    Time frame: 64 weeks

Secondary outcomes

  1. Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life

    Time frame: 64 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

Registry information

Official study title

An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Important dates

Study start
2007
Primary completion
2009
First posted
Aug 8, 2007
Registry last updated
Jun 13, 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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