NCT00212732

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

September 13, 2005

Last Update Submit

October 10, 2012

Conditions

Overactive Bladder

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Total number of urinary incontinence episodes per week

Secondary Outcomes (1)

  • Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

Interventions

ONO-8025 (KRP-197)DRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37160401DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

imidafenacin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2003

Primary Completion

April 1, 2006

Last Updated

October 11, 2012

Record last verified: 2012-10