Small intestinal mucosal adaptation in the long-term administration of a NSAID and the efficacy of irsogladine maleate, a gastroprotective drug, and omeprazole in healthy volunteers: a prospective randomized trial

Small intestinal mucosal adaptation in the long-term administration of a NSAID and the efficacy of irsogladine maleate, a gastroprotective drug, and omeprazole in healthy volunteers: a prospective randomized trial - Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Small Intestinal Lesions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007540

Enrollment

Registered

2012-03-21

Start date

2010-04-01

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

NSAID induced small intestinal lesions

Interventions

irsogladine 4mg/day and dicrofenacNa75mg/day for 6weeks in oral administration omeprazole 10mg/day and dicrofenacNa75mg/day for 6weeks in oral administration After that omeprazole 10mg/day, dicrofena

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining consent 2) Subjects from whom fully informed written consent based on their full understanding and their own voluntary will was obtained when participating this study

Exclusion criteria

Exclusion criteria: 1) Subjects with a history of peptic ulcer or gastrointestinal bleeding 2) Subjects with significant hepatic disease, renal disease, heart disease, or respiratory disease 3) Subjects with a history of gastrointestinal surgery other than appendectomy 4) Subjects orally taking or planning to orally take drug other than antiulcer drug or NSAIDs 5) Subjects with alcohol or chemical dependencies 6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal obstruction on other tests 7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body 8) Subjects whom otherwise the investigator determined ineligible as the subject

Design outcomes

Primary

Measure	Time frame
The number of small intestinal mucosal breaks evaluated in the capsule endoscope.	—

Secondary

Measure	Time frame
1. fecal calprotectin 2. hemoglobin 3. occult fecal blood test	—

Countries

Japan

Outcome results

None listed

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