Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients

Launched by LIVZON PHARMACEUTICAL GROUP INC. · Jul 25, 2016

Keywords

ClinConnect Summary

The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels. Stages of the ulcers were endoscopically assessed according to the degree of ulceration, regenerating epithelialization, and scarring, which was defined as follows: A stage (active stage, A1 \& A2) where A1 stage is more severe than A2 stage, H stage (healing stage, H1 \& H2) where H2 stage is better than H1 stage, and S stage (scarring stage, S1 (red scar) \& S2 (white scar)) where S stage is the best stage in the three s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * - Consenting patients were eligible for enrollment if they:
• • 1. were 18-65 years of age,
• • 2. had endoscopically diagnosed active duodenal ulcers within the previous 72 hours,
• • 3. the number of ulcers was at least one, but no more than two with the larger diameter 0.3-2.0cm.
• Exclusion Criteria:
• * - Patients were ineligible if they:
• • 1. had cancerous or complex ulcers, Zollinger-Ellison syndrome, esophageal erosion or ulcer, varices of esophagus or fundus of stomach, or pyloric stenosis,
• • 2. had a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
• • 3. had severe complications (e.g., pyloric obstruction, active bleeding under endoscope), severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
• • 4. were female patients who were breast feeding, pregnant, or intended to become pregnant during the study,
• • 5. had taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
• • 6. participated in a clinical trial with an investigational drug or device within the past three months,
• • 7. had hypersensitivity or idiosyncratic reaction to omeprazole or any other benzimidazole,
• • 8. had alcoholic intemperance, drug addiction or any other improper habits.