Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into four groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of ilaprazole, 5, 10, and 20 mg/day, and one of omeprazole 20 mg/day as positive control. The primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated as secondary end points by using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Livzon Pharmaceutical Group Inc.
• Treatments: Omeprazole

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.