Study of ONO-8539 in Patients With Overactive Bladder

This study is not yet open for participant recruitment.

Verified by Ono Pharma, April 2009

First Received: April 2, 2009 Last Updated: April 3, 2009 History of Changes

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00876421

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 II

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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

Further study details as provided by Ono Pharma:

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 ]

Estimated Enrollment:	400
Study Start Date:	April 2009
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Placebo Comparator	Drug: Placebo Placebo / 12 weeks
A: Active Comparator	Drug: Tolterodine 4mg / 12 weeks
E1: Experimental	Drug: ONO-8539 low dose / 12 weeks
E2: Experimental	Drug: ONO-8539 medium dose / 12 weeks
E3: Experimental	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

Contacts

Contact: Tomohiro Kuwayama

t-kuwayama@ono.co.uk

Show 50 Study Locations

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Tomohiro Kuwayama

Clinical Development, ONO Pharma UK, Ltd

More Information

No publications provided

Responsible Party:	Development Headquarters, ONO Pharmaceutical Co., Ltd. ( Hiroshi Awata, Executive Director, Development Headquarters )
Study ID Numbers:	ONO-8539POE004
Study First Received:	April 2, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876421 History of Changes
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 and Social Development 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 Pharma:

ONO-8539
Overactive bladder
OAB

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele

Cholinergic Antagonists
Urologic Diseases
Urinary Bladder Diseases
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Tolterodine

ClinicalTrials.gov processed this record on May 07, 2009