Therapeutic Efficacy of Gliptide(R) (Sulglycotide) on Gastritis - A Double Blind, Randomized, Active Drug Comparative, Multi-Center, Phase IV Study

ABSTRACT

BACKGROUND/AIMS: Sulglycotide is a sulphoglycopeptide isolated from porcine duodenal mucosa. It has antiulcer and cytoprotective activity with anti Helicobacter pylori (H. pylori) effect. This study was performed to assess the therapeutic efficacy and safety of gliptide(R) (sulglycotide) in comparison with another mucosal protective agent, selbex(R) (teprenone) for the treatment of gastritis. MATERIALS AND METHODS: One hundred and twenty one patients with symptomatic erosive gastritis were randomized to receive sulglycotide (gliptide(R)) or teprenone (selbex(R)) for 4 weeks. Improvement and cure rates on endoscopic findings, improvement rates of symptoms, and eradication rates of H. pylori were compared. RESULTS: Of the 121 intention-to-treat (ITT) population, 82 patients comprised the per protocol (PP) analysis. Endoscopic cure rates and improvement rates in the sulglycotide and teprenone group were 36.7% vs. 29.5% and 41.7% vs. 37.7% in ITT and 46.3% vs. 34.2% and 53.7% vs. 43.9% in PP population, respectively. Symptom improvement rates in the sulglycotide and teprenone group were 71.7% vs. 65.6% in ITT and 85.4% vs. 75.6% in PP. Eradication rates of H. pylori were not significantly different between the groups. Results of 95% CIs for the difference in endoscopic cure rate and improvement rate, symptom improvement rate, and eradication rate of H. pylori between the two groups met the criteria for the non-inferiority of sulglycotide to teprenone. No significant adverse events were encountered during the study period. CONCLUSIONS: Gliptide(R) (sulglycotide) is not inferior to selbex(R) (teprenone) in therapeutic efficacy and is a safe and useful therapeutic agent for the treatment of gastritis.