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 (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Hungary: National Institute of Pharmacy
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Ono Pharmaceutical Co. Ltd:
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations processed this record on May 03, 2016