Clinical trial to explore Irsogladine maleate in NSAID or aspirin induced peptic ulcer and gastritis preventio

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0002319
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

There were no significant differences in gastric protective effects between test and placebo groups. However, two cases of peptic ulcer in the placebo group but none in the test group were observed. These two cases of peptic ulcer were Helicobacter pylori-negative. In addition, H. pylori-negative group showed significant changes in MLS score (p = 0.0247) and edema score (p = 0.0154) after the treatment compared to those before treatment in the test group. There was no significant difference in adverse events between the two groups. In conclusion, the efficacy of irsogladine maleate was found in H. pylori-negative group, suggesting its potential as a protective agent against NSAIDs or aspirin-induced peptic ulcer and gastritis.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1) older than 50
2) under condition to take continuous NSAID(non-steroidal anti-inflammatory drugs) or aspirin(>80mg/day) therapy longer than 8 weeks
3) volentary agreement with signed informed consent

Exclusion Criteria

1) surgery history to reduce gastric acid secretion or esophagogastric surgery other than simple ulcer closure
2) Zollinger-Ellison syndrome
3) active peptic ulcer or acute erosive gastritis (by screening endoscopy)
4) gastroesophageal reflux disease ( = Los Angeles classification grade A)
5) bleeding or coagulation disorder
6) inflammatory bowel disease
7) surgery schedule during study period for NSAIDs(non-steriodal anti-inflammatory drugs) related pathologic findings or gastric infiltration
8) history of malabsorption, esophageal stricture, esophagitis, endoscopic Barrett’s esophagus >3 cm within 3months
9) uncontrolled hypertension (>160/95mmHg) at screening
10) clinically meaningful kidney dysfunction (serum creatinine>3mg/dl)
11) clinically meaningful liver dysfunction (>2.5 times of normal Aspartate aminotransferase/Alanin aminotransferase level)
12) BUN(blood urea nitrogen) > 50mg/dl by screening test
13) bilirubin > 3mg/dl by screening test (excluding Gilbert's syndrome)
14) treatment history with Proton pump inhibitors, H2 blockers, muscarine receptor antagonist, anti-gastrin agent, corticosteroid (excluding local application), antacid, mucoprotective agent, anticoagulant (besides aspirin), antiplatelet agent, bisphosphonate, anticontroversy, anti-cholinergic angent for gastro-intestinal purpose, prokinetics within 2 weeks
15) condition to take immunosuppressive drug
16) surgery history to influence gastric acid secretion
17) known hypersensitivity to study medications of irsogladine maleate
18) galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
19) cancer history within 5 years
20) pregnancy or lactation
21) pregnancy possibility during study period
22) alcohol or drug addiction
23) other clinical study participants within 30 days
24) investigator's judge of inappropiation

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
peptic ulcer(Modified Lanza Score 5) occurrence confirmed by endoscopy (%);gastitis(Modified Lanza Score 2-4) occurrence by endoscopy (%)

Secondary Outcome Measures

Name	Time	Method
number of acute erosive gastitis by endoscopy;MDA (malondialdehyde) level change;edema score change by endoscopy;redness score change by endoscopy;hemorrhage score change by endoscopy;Korean-Nepean Dyspeptic Index(K-NDI) survey score change