Status:
UNKNOWN
Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
NSAIDs-associated Intestinal Mucosal Injury
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 end...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05249725
Start Date
April 1 2022
End Date
April 1 2023
Last Update
April 4 2022
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