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

NCT05249725 | Unknown Phase 4

• 1 other identifier: GSL-LEES-2021-12
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

NSAIDs-associated Intestinal Mucosal Injury

Keywords

NSAIDs, intestinal mucosal injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Irsogladine Maleate

EXPERIMENTAL

Drug: Irsogladine Maleate

Hydrotalcite

PLACEBO COMPARATOR

Drug: Hydrotalcite

Interventions

Irsogladine Maleate DRUG

Orally administration of irsogladine maleate 4mg/day, for 8 weeks.

Irsogladine Maleate

Hydrotalcite DRUG

Patients were given 1 g hydrotalcite every morning, afternoon and evening for 8 weeks.

Hydrotalcite

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);
• Patients taking antisecretory drugs such as proton pump inhibitors or H2 receptor antagonists and gastric mucosal protectors such as rebapide or tiprexone were eligible;
• Willing to sign informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Interventions

irsogladine; hydrotalcite

Central Study Contacts

HAN SHIJI

CONTACT

13929517813; shiji.han@leespharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 22, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03