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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512785
First Posted: August 8, 2007
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kyorin Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00512785     History of Changes
Other Study ID Numbers: KRP197-T301/ONO-8025-12
First Submitted: August 7, 2007
First Posted: August 8, 2007
Last Update Posted: June 13, 2012
Last Verified: June 2012

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms