Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions

Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions - Influence of proton pump inhibitors on nonsteroidal anti-inflammatory drug-induced small-intestinal lesions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024833

Enrollment

Registered

2016-11-15

Start date

2016-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonsteroidal antiinflammatory drug induced small intestinal lesions

Interventions

Diclofenac at 75 mg/day was orally administered after every meal (3 times a day), and vonoprazan at 20 mg after breakfast (once a day) for 14 days Diclofenac at 75 mg/day was orally administered after

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who are not being orally treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (2) Those who are not being orally treated with PPI, H2 receptor antagonists, mucoprotective drugs, or prokinetics (3) Those from whom written informed consent regarding participation in this study was obtained.

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Number of mucosal breaks (erosion, ulcer) in the small intestine on capsule endoscopy at the completion of administration	—

Secondary

Measure	Time frame
Number 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	—

Countries

Japan

Contacts

Public ContactYuichi Kojima

Osaka Medical College Endoscopy Center

in2134@osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026