Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions
- Conditions
- nonsteroidal antiinflammatory drug induced small intestinal lesions
- Registration Number
- JPRN-UMIN000024833
- Lead Sponsor
- Second Department of Internal Medicine, Osaka Medical College
- Brief Summary
terminate this trial to change the protocol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(1)a history of allergy to diclofenac, rabeprazole, vonoprazan (2)a history of peptic ulcers or gastrointestinal bleeding, ulcerative colitis, Crohn' s disease (3)a history of gastrointestinal surgery other than appendectomy (4)a history of intestinal obstruction or suspected gastrointestinal obstruction on other tests (5)significant hepatic, renal, heart, or respiratory disease (6)Pregnant women, those who may become pregnant during the study period, and lactating women (7)a lack of consent for the surgery required if the capsule endoscope was retained within the body (8)determination by the investigator (at his/her discretion) that the subject was ineligible for participation in the study for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of mucosal breaks (erosion, ulcer) in the small intestine on capsule endoscopy at the completion of administration
- Secondary Outcome Measures
Name Time Method umber of sites of redness in the small intestine on capsule endoscopy at the completion of administration, Lewis score, fecal Calprotectin, serum DAO activity, and adverse effects