Dose finding study of JTE-051
Phase 2
Recruiting
- Conditions
- Interstitial Cystitis/Bladder Pain Syndrome
- Registration Number
- JPRN-jRCT2031210042
- Lead Sponsor
- Koretomo Ryosuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Diagnosed with interstitial cystitis or bladder pain syndrome
2. Japanese patient aged >=20 and <75 at the time of informed consent
3. Satisfied with protocol-defined criteria for NRS average bladder pain score, ICSI score, and daily urinary frequency
Exclusion Criteria
1. Have been received therapies (e.g., transurethral resection/fulguration, intravesical instillation, or hydrodistension) during protocol-specified period
2. Have history of augmentation cystoplasty, cystectomy or urinary diversion
3. Found to meet protocol-defined conditions determined by screening results (e.g., laboratory tests)
4. Presence of severe hepatic diseases
5. Presence or history within 5 years of malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in NRS average bladder pain score
- Secondary Outcome Measures
Name Time Method