NCT05249725

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this prospective randomized controlled study, 100 patients with NSAIDS-related intestinal mucosal injury will be enrolled in 10 clinical centers across China from July 2021 to December 2022. 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. Laboratory tests including blood routine, stool routine, and occult blood were performed at the beginning and end of the study. Abdominal symptoms and signs were assessed by two experienced clinicians at week 0, 1, 2, and 4 (8) of the study.

Conditions

• NSAIDs-associated Intestinal Mucosal Injury

Interventions

Type	Name	Description
DRUG	Irsogladine Maleate	Orally administration of irsogladine maleate 4mg/day, for 8 weeks.
DRUG	Hydrotalcite	Patients were given 1 g hydrotalcite every morning, afternoon and evening for 8 weeks.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-08-01
• Completion: 2023-04-01
• First posted: 2022-02-22
• Last updated: 2022-04-04