Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis
Phase 2
Recruiting
- Conditions
- Crohn's disease
- Registration Number
- JPRN-jRCT1051190043
- Lead Sponsor
- Takehara Tetsuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Mild to moderate active Crohn's disease patients with written consent at Osaka University Hospital and affiliated hospitals, who have intestinal stenosis and are scheduled or recieved endoscopic balloon dilation (EBD), are included.
Exclusion Criteria
Patients with more than 5 centimeters long stenosis
Patients with internal or external fistula
Patients with active infection, including abscess
Patients with oral treatment of antithrombotic drugs or low platelet that counts less than 50000 per microlitter
Patients with cancer
Patients under 20 years old
Patients with severy bad general condition
Patients who are administered steroids within 4 weeks
Patients who are judged inapropriate by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety within 12 weeks after EBD
- Secondary Outcome Measures
Name Time Method Safety within 52 weeks after EBD <br>Rate of non-intestinal resection, non-reEBD and non-hospitalization <br>Rate of non-restenosis at 52 weeks after EBD