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

This study has been completed.
Sponsor:
Collaborator:
Kyorin Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00512785
First received: August 7, 2007
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Overactive Bladder
 Drug: imidafenacin, KRP-197/ONO-8025
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Enrollment: 435
Study Start Date: August 2007
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E1 Drug: imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 52 weeks
Experimental: E2 Drug: imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512785

Locations
Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Kyorin Pharmaceutical Co.,Ltd
Investigators
Study Director: Yoshifumi Hirahara Kyorin Pharmaceutical Co.,Ltd
Study Chair: Toshihiko Konomi Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00512785     History of Changes
Other Study ID Numbers: KRP197-T301/ONO-8025-12
Study First Received: August 7, 2007
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
Imidafenacin
KRP-197/ONO-8025
overactive bladder
antimuscarinic

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013