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Study of ONO-8539 in Patients With Overactive Bladder

This study has been completed.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd Identifier:
First received: April 2, 2009
Last updated: June 12, 2012
Last verified: June 2012
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Condition Intervention Phase
Overactive Bladder
Drug: Placebo
Drug: Tolterodine
Drug: ONO-8539
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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

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

Enrollment: 435
Study Start Date: April 2009
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00876421

  Show 50 Study Locations
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Tomohiro Kuwayama Clinical Development, ONO Pharma UK, Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00876421     History of Changes
Other Study ID Numbers: ONO-8539POE004
Study First Received: April 2, 2009
Last Updated: June 12, 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 processed this record on May 25, 2017