NCT00512785

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
435

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

2 active sites

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

August 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

August 7, 2007

Last Update Submit

June 12, 2012

Conditions

Overactive Bladder

Keywords

ImidafenacinKRP-197/ONO-8025overactive bladderantimuscarinic

Outcome Measures

Primary Outcomes (1)

  • Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume

    64 weeks

Secondary Outcomes (1)

  • Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life

    64 weeks

Study Arms (2)

E1

EXPERIMENTAL
Drug: imidafenacin, KRP-197/ONO-8025

E2

EXPERIMENTAL
Drug: imidafenacin, KRP-197/ONO-8025

Interventions

imidafenacin, KRP-197/ONO-8025DRUG

0.1 mg BID for 52 weeks

E1

Eligibility Criteria

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

You may qualify if:

  • Men and Woman equal or \> 20 years old
  • Patients with urgency, urinary frequency and urgency incontinence

You may not qualify if:

  • Patients with genuine stress incontinence
  • Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
  • Patients suffering from complications contraindicating the use of antimuscarinic medication
  • Patients with polyuria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kanto Region

Kanto, Japan

Location

Kinki Region

Kinki, Japan

Location

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

  • Yoshifumi Hirahara

    Kyorin Pharmaceutical Co.,Ltd

    STUDY DIRECTOR

  • Toshihiko Konomi

    Ono Pharmaceutical Co. Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(2)