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Study of ONO-8539 in Patients With Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Tolterodine
ONO-8539
ONO-8539
ONO-8539
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring ONO-8539, Overactive bladder, OAB

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

P

A

E1

E2

E3

Arm Description

Outcomes

Primary Outcome Measures

Overactive bladder symptoms

Secondary Outcome Measures

Overactive bladder symptoms (QOL)

Full Information

First Posted
April 2, 2009
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00876421
Brief Title
Study of ONO-8539 in Patients With Overactive Bladder
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
ONO-8539, Overactive bladder, OAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Title
A
Arm Type
Active Comparator
Arm Title
E1
Arm Type
Experimental
Arm Title
E2
Arm Type
Experimental
Arm Title
E3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo / 12 weeks
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Intervention Description
4mg / 12 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-8539
Intervention Description
low dose / 12 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-8539
Intervention Description
medium dose / 12 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-8539
Intervention Description
higher dose / 12 weeks
Primary Outcome Measure Information:
Title
Overactive bladder symptoms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overactive bladder symptoms (QOL)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomohiro Kuwayama
Organizational Affiliation
Clinical Development, ONO Pharma UK, Ltd
Official's Role
Study Director
Facility Information:
City
Brno
Country
Czech Republic
City
Jindrichuv Hradec
Country
Czech Republic
City
Olomouc
Country
Czech Republic
City
Opava
Country
Czech Republic
City
Plzen
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Steti
Country
Czech Republic
City
Usti Nad Labem
Country
Czech Republic
City
Duisburg
Country
Germany
City
Hagenow
Country
Germany
City
Krumbach
Country
Germany
City
Magdeburg
Country
Germany
City
Mulheim
Country
Germany
City
Weiden
Country
Germany
City
Budapest
Country
Hungary
City
Dombovar
Country
Hungary
City
Nyiregyhaza
Country
Hungary
City
Szeged
Country
Hungary
City
Szekszard
Country
Hungary
City
Den Haag
Country
Netherlands
City
Heerlen
Country
Netherlands
City
Maastricht
Country
Netherlands
City
Tilburg
Country
Netherlands
City
Winterswijk
Country
Netherlands
City
Bialystok
Country
Poland
City
Bielsko-Biala
Country
Poland
City
Gdansk
Country
Poland
City
Gdynia
Country
Poland
City
Katowice
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Myslowice
Country
Poland
City
Warszawa
Country
Poland
City
Arad
Country
Romania
City
Bihor
Country
Romania
City
Bucharest
Country
Romania
City
Timis
Country
Romania
City
Moscow
Country
Russian Federation
City
Rostov-on-Don
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Goteborg
Country
Sweden
City
Kungalv
Country
Sweden
City
Stockholm
Country
Sweden
City
Umea
Country
Sweden
City
Uppsala
Country
Sweden
City
Chernivtsi
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Study of ONO-8539 in Patients With Overactive Bladder

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