Randomized controlled trial of the effect of irsogladine maleate on the mucosal injury of small intestine in regular users of loxoprofen sodium

Randomized controlled trial of the effect of irsogladine maleate on the mucosal injury of small intestine in regular users of loxoprofen sodium - Randomized controlled trial of the effect of irsogladine maleate on the small intestinlal lesions in NSAID users

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001507

Enrollment

Registered

2008-11-15

Start date

2008-11-01

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

mucosal injury of small intestine due to NSAID

Interventions

irsogladine maleate no treatment control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) regular users of NSAID who have already used NSAID (e.g. loxoprofen) more than 4 weeks, and continue to use further over 8weeks 2) patients with small intestinal lesions detected by screening capsule endoscopy are entered to RCT for treatment by irsogladine maleate

Exclusion criteria

Exclusion criteria: 1) patients taking misoprostol 2) patients taking other NSAIDs, steroid, anti-platelet agents except aspirin, anti-coagulants, or anti-cancer drugs 3) patients with contraindication to capsule endoscopy 4) patients with active bleeding lesions 5) severely ill patients

Design outcomes

Primary

Measure	Time frame
grade, number, and improvement of small intestinal lesions evaluated by capsule endoscopy	—

Countries

Japan

Outcome results

None listed

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