Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Detailed Description

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Conditions

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Overactive Bladder

Keywords

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ONO-8025, KRP-197, overactive bladder, antimuscarinic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ONO-8025 (KRP-197)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over

Exclusion Criteria

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exlcusion criteria as specified in the study protocol

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader, Development Planning

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

References

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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type DERIVED

PMID: 37160401 (View on PubMed)

Other Identifiers

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ONO-8025-08

Identifier Type: -

Identifier Source: org_study_id