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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00742833
Other study ID # KUC1203
Secondary ID
Status Completed
Phase Phase 2
First received August 5, 2008
Last updated September 2, 2009

Study information

Verified date September 2009
Source Kissei 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

To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients with a symptom of overactive bladder for more than 6 months.

- Patients who meet the following condition during the 3-day bladder diary period.

- the mean number of micturitions per 24 hours is =8 times

- the mean number of urgency episodes per 24 hours is =1 time

Exclusion Criteria:

- Patients who are diagnosed as stress urinary incontinence are predominant.

- Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
KUC-7483

Placebo


Locations

Country Name City State
Japan Japan Hokkaido region
Japan Japan Kansai region
Japan Japan Kanto region
Japan Japan Kyushu region
Japan Japan Shikoku region
Japan Japan Tohoku region

Sponsors (1)

Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in mean number of micturitions per 24 hours 12 weeks No
Secondary Change from baseline in mean number of urgency episodes per 24 hours 12 weeks No
Secondary Change from baseline in mean number of incontinence episodes per 24 hours 12 weeks No
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