Status:
COMPLETED
Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)
Lead Sponsor:
Livzon Pharmaceutical Group Inc.
Conditions:
Duodenal Ulcer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 tr...
Detailed Description
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 end...
Eligibility Criteria
Inclusion
- Consenting patients were eligible for enrollment if they:
- were 18-65 years of age,
- had endoscopically diagnosed active duodenal ulcers within the previous 72 hours,
- the number of ulcers was at least one, but no more than two with the larger diameter 0.3-2.0cm.
Exclusion
- Patients were ineligible if they:
- had cancerous or complex ulcers, Zollinger-Ellison syndrome, esophageal erosion or ulcer, varices of esophagus or fundus of stomach, or pyloric stenosis,
- had a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
- 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,
- were female patients who were breast feeding, pregnant, or intended to become pregnant during the study,
- 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,
- participated in a clinical trial with an investigational drug or device within the past three months,
- had hypersensitivity or idiosyncratic reaction to omeprazole or any other benzimidazole,
- had alcoholic intemperance, drug addiction or any other improper habits.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00953381
Start Date
October 1 2004
End Date
May 1 2005
Last Update
August 6 2009
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China