Study of ONO-8539 in Patients With Overactive Bladder


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateMay 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: April 3, 2009)		Overactive bladder symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00876421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: April 3, 2009)		Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy of ONO-8539 in Patients With Overactive Bladder
Official Title  ICMJEA 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
Brief Summary

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

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJEOveractive Bladder
Intervention  ICMJE
  • Drug: Placebo
    Placebo / 12 weeks
  • Drug: Tolterodine
    4mg / 12 weeks
  • Drug: ONO-8539
    low dose / 12 weeks
  • Drug: ONO-8539
    medium dose / 12 weeks
  • Drug: ONO-8539
    higher dose / 12 weeks
Study Arms / Comparison Groups
  • P: Placebo Comparator
    Intervention: Drug: Placebo
  • A: Active Comparator
    Intervention: Drug: Tolterodine
  • E1: Experimental
    Intervention: Drug: ONO-8539
  • E2: Experimental
    Intervention: Drug: ONO-8539
  • E3: Experimental
    Intervention: Drug: ONO-8539

Recruitment Information

Estimated Enrollment  ICMJE400
Completion Date 
Estimated Primary Completion DateMay 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Tomohiro Kuwayamat-kuwayama@ono.co.uk
Location Countries  ICMJECzech Republic,   Germany,   Hungary,   Netherlands,   Poland,   Romania,   Russian Federation,   Sweden,   Ukraine

Administrative Information

NCT ID  ICMJENCT00876421
Responsible PartyHiroshi Awata, Executive Director, Development Headquarters, Development Headquarters, ONO Pharmaceutical Co., Ltd.
Study ID Numbers  ICMJEONO-8539POE004
Study Sponsor  ICMJEOno Pharma
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Tomohiro KuwayamaClinical Development, ONO Pharma UK, Ltd
Information Provided ByOno Pharma