Phase III study of KRP-116D
Phase 3
Completed
- Conditions
- Interstitial cystitis( IC )
- Registration Number
- JPRN-jRCT2080223511
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
Efficacy of the KRP-116D compared with placebo was evaluated
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 109
Inclusion Criteria
Diagnosed with IC
Exclusion Criteria
Patients has complication or past history within 5 years with cancer
Patients complicated with urinary tract/genital infection
Patients has past history with augmentation cystoplasty or cystectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy(O'Leary and Sant's IC symptom index)<br>Questionnaire
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy(O'Leary and Sant's IC problem index, urinary symptom, bladder pain score,etc.), Safety<br>Questionnaire, Symptom dairy, Adverse event and adverse drug reaction