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Study of ONO-8539 in Patients With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00876421
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Brief Summary:
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Placebo Drug: Tolterodine Drug: ONO-8539 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2009
Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: P Drug: Placebo
Placebo / 12 weeks
Active Comparator: A Drug: Tolterodine
4mg / 12 weeks
Experimental: E1 Drug: ONO-8539
low dose / 12 weeks
Experimental: E2 Drug: ONO-8539
medium dose / 12 weeks
Experimental: E3 Drug: ONO-8539
higher dose / 12 weeks

Primary Outcome Measures :
  1. Overactive bladder symptoms [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876421

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Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Tomohiro Kuwayama Clinical Development, ONO Pharma UK, Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00876421     History of Changes
Other Study ID Numbers: ONO-8539POE004
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents