Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
Primary Purpose
NSAIDs-associated Intestinal Mucosal Injury
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Irsogladine Maleate
Hydrotalcite
Sponsored by
About this trial
This is an interventional treatment trial for NSAIDs-associated Intestinal Mucosal Injury focused on measuring NSAIDs, intestinal mucosal injury
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Irsogladine Maleate
Hydrotalcite
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05249725
First Posted
January 19, 2022
Last Updated
March 23, 2022
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT05249725
Brief Title
Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
Official Title
Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSAIDs-associated Intestinal Mucosal Injury
Keywords
NSAIDs, intestinal mucosal injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irsogladine Maleate
Arm Type
Experimental
Arm Title
Hydrotalcite
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Irsogladine Maleate
Intervention Description
Orally administration of irsogladine maleate 4mg/day, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Hydrotalcite
Intervention Description
Patients were given 1 g hydrotalcite every morning, afternoon and evening for 8 weeks.
Primary Outcome Measure Information:
Title
Number of small intestinal mucosal lesions under capsule endoscopy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAN SHIJI
Phone
13929517813
Email
shiji.han@leespharm.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
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