Single Blinded, Randomized, Active Drug Comparative, Multi-center Study to Evaluate the Therapeutic Efficacy of Gliptide(R)Tab (Sulglycotide 200 mg) in Gastritis Patients; Phase IV Study

Jeong, Jeong Jo; Choi, Myung Gyu; Choi, Hwang; Park, Jae Myung; Oh, Jung Hwan; Jeon, Eun Jeong; Lee, Bo In; Lee, In Seok; Kim, Sang Woo; Choi, Sang Wook; Choi, Gyu Yong; Chung, In Sik

Abstract

BACKGROUND/AIMS: Sulglycotide is a sulphoglycopeptide with antiulcer and cytoprotective activity that is derived from the porcine duodenal mucosa. This study carried out a 3-week single blinded, randomized, multicenter, noninferiority trial to compare the efficacy of oral sulglycotide in treating symptomatic erosive gastritis with that of rebamipide.
METHODS
Seventy-three patients with symptomatic erosive gastritis were randomized to receive 3 weeks of treatment with either sulglycotide or rebamipide. The primary efficacy parameter was the endoscopic cure rate and the endoscopic improvement rate, and the secondary parameter was the improvement rate in the dyspepsia symptom scores.
RESULTS
Of the 73 patients recruited, 36 received sulglycotide and 37 received rebamipide. The endoscopic cure rate in the sulgycotide and rebamipide group was 29.6% and 25.0% according to per protocol (PP) analysis, respectively (p=0.69). The endoscopic improvement rate in the sulglycotide and rebamipide group was 63.0% and 62.5% according to PP analysis, respectively (p=0.97). The symptomatic improvement rate in the sulgycotide and rebamipide group was 51.9% and 53.1% according to PP analysis, respectively (p=0.74). The result of 90% CIs for the difference in endoscopic cure rate, endoscopic improvement rate and symptom improvement rate between the two groups met the criteria for the non-inferiority of sulglycotide to rebamipide.
CONCLUSIONS
Sulglycotide was not inferior to rebamipide in both erosion healing and symptom relief in patients with acute and chronic gastritis.