drugset / Trial / NCT05249725

Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population

NCT05249725

Phase 4 Unknown 100 enrolled Lee's Pharmaceutical Limited
RandomizedParallel-groupTriple-blindTreatment

Summary

All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa.

Timeline

Start
2022-04
Primary completion
2022-08
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator HYDROTALCITE ANHYDROUS Small molecule 1 g
Subject Irsogladine Small molecule 4 mg Oral