Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512785
• Other study ID #: KRP197-T301/ONO-8025-12
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2007
• Last updated: June 12, 2012
• Start date: August 2007

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Men and Woman equal or > 20 years old

• Patients with urgency, urinary frequency and urgency incontinence

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 52 weeks
• imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks

Locations

Country	Name	City	State
Japan	Kanto Region	Kanto
Japan	Kinki Region	Kinki

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd	Kyorin Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume		64 weeks	Yes
Secondary	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	No