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NCT00876421 Clinical Trial

Study of ONO-8539 in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00876421
Other study ID # ONO-8539POE004
Secondary ID
Status Completed
Phase Phase 2
First received April 2, 2009
Last updated June 12, 2012
Start date April 2009

Study information
Verified date June 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of PharmacyGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencyCzech Republic: State Institute for Drug ControlRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of HealthRomania: National Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 435
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo / 12 weeks
• Tolterodine
4mg / 12 weeks
• ONO-8539
low dose / 12 weeks
• ONO-8539
medium dose / 12 weeks
• ONO-8539
higher dose / 12 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Netherlands,  Poland,  Romania,  Russian Federation,  Sweden,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overactive bladder symptoms 12 weeks No
Secondary Overactive bladder symptoms (QOL) 12 weeks No
See also
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Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Completed NCT01122550 - Reproducibility Study of Overactive Bladder Symptom Score [OABSS] N/A