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

A randomized, double-blind, multicenter clinical trial, Pilot study to evaluate the efficacy and safety of Irsogladine maleate in NSAID or Aspirin induced peptic ulcer and gastritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002319

Enrollment

Registered

2017-05-10

Start date

2015-01-05

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : (Control arm) Placebo Gaslon N® ODT/tablet, 1 tablet/time, 2times/day, 8 weeks, per oral (Test arm) Gaslon N® ODT 2mg/tablet, 1 tablet/time, 2times/day, 8 weeks, per oral

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
peptic ulcer(Modified Lanza Score 5) occurrence confirmed by endoscopy (%);gastitis(Modified Lanza Score 2-4) occurrence by endoscopy (%)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactNa Young Kim

Seoul National University Bundang Hospital

nakim@snubh.org+82-1588-3369

Outcome results