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Completed

NCT Number: NCT00876421

Study of ONO-8539 in Patients With Overactive Bladder

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 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

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with medical history of Overactive Bladder symptoms for > 6 months

Exclusion criteria

  • Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

Treatment and study plan

Placebo

Drug

Placebo / 12 weeks

tolterodine

Drug

4mg / 12 weeks

ONO-8539

Drug

low dose / 12 weeks

Primary outcomes

  1. Overactive bladder symptoms

    Time frame: 12 weeks

Secondary outcomes

  1. Overactive bladder symptoms (QOL)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder

Important dates

Study start
2009
Primary completion
2010
First posted
Apr 6, 2009
Registry last updated
Jun 14, 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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