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Status unknownNCT05249725Updated Apr 4, 2022

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

A Phase 4 interventional study of Irsogladine Maleate and Hydrotalcite in NSAIDs-associated Intestinal Mucosal Injury, sponsored by Lee's Pharmaceutical Limited. Status unknown. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Lee's Pharmaceutical Limited · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • NSAIDs-associated Intestinal Mucosal Injury

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Keywords

  • NSAIDs, intestinal mucosal injury
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 100 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Lee's Pharmaceutical Limited is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Irsogladine Maleate

    Drug: Irsogladine Maleate

  • Placebo comparator
    Hydrotalcite

    Drug: Hydrotalcite

Interventions

  • DrugIrsogladine Maleate

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

  • DrugHydrotalcite

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

06

What researchers measure

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.

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05249725
Lead sponsor
Lee's Pharmaceutical Limited
Responsible party
Sponsor
First posted
Feb 22, 2022
Start date
Apr 2022 (estimated)
Primary completion
Aug 2022 (estimated)
Completion
Apr 2023 (estimated)
Last update
Apr 4, 2022

Study contacts

HAN SHIJI
Contact
shiji.han@leespharm.com
13929517813

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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