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Study of ONO-8539 in Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00876421
First received: April 2, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876421

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov 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:
ONO-8539
Overactive bladder
OAB

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

ClinicalTrials.gov processed this record on June 17, 2013