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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSAIDs-associated Intestinal Mucosal Injury
• Intervention / Treatment: Drug: Irsogladine Maleate; Drug: Hydrotalcite

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: HAN SHIJI; Phone Number: 13929517813; Email: shiji.han@leespharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Within 4 weeks before the study, NSAIDs were taken at least once a day with symptoms and signs of abdominal discomfort, such as abdominal pain, abdominal distension and dyspepsia;
2. During the 8-week observation period of the study, NSAIDs will continue to be used in the same protocol (whether to stop NSAIDs during the study remains to be determined);
3. Patients taking antisecretory drugs such as proton pump inhibitors or H2 receptor antagonists and gastric mucosal protectors such as rebapide or tiprexone were eligible;
4. Willing to sign informed consent

Exclusion Criteria:

1. Active gastrointestinal bleeding;
2. Taking more than two NSAIDs, anticoagulants, steroid hormones or prostaglandin derivatives;
3. Have a history of gastrointestinal surgery except appendectomy;
4. Suspected small bowel obstruction;
5. gastroduodenal ulcer;
6. Severe cardiopulmonary diseases (NYHA grade IV cardiac function or respiratory failure);
7. Significant renal impairment (serum creatinine ≥2 mg/dL or glomerular filtration rate GFR<40 mL/min);
8. Liver insufficiency (liver function: total bilirubin >ULN, ASpartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≥ 2.0 × ULN);
9. Confirmed or suspected combined with malignant tumor;
10. pregnant and lactation women or women who do not exclude the possibility of pregnancy;
11. Drug addicts or alcoholics;
12. Participants in other drug trials within 3 months;
13. The researcher considers it unsuitable for participants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irsogladine Maleate	Drug: Irsogladine Maleate; Orally administration of irsogladine maleate 4mg/day, for 8 weeks.
Placebo Comparator: Hydrotalcite	Drug: Hydrotalcite; Patients were given 1 g hydrotalcite every morning, afternoon and evening for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of small intestinal mucosal lesions under capsule endoscopy	After 8 weeks of treatment, capsule endoscopy was repeated, and the number of small intestinal mucosal lesions under the microscope decreased by ≥1 or the Lewis score decreased by more than before, which was considered effective.	8 weeks

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: NSAIDs, intestinal mucosal injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Anticarcinogenic Agents; Radiation-Protective Agents; Antacids; Hydrotalcite; Irsogladine
• Other Study ID Numbers: GSL-LEES-2021-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No