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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00952978 |
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Date of registration:
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05/08/2009 |
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Primary sponsor: |
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Public title:
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Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 3)
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Scientific title:
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Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase3 Trial in China |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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496 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00952978 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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S R Lin, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking University Third Hospital |
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Key inclusion & exclusion criteria
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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
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Duodenal Ulcer
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Intervention(s)
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Drug: 10 mg ilaprazole
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Drug: 20 mg omeprazole
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Primary Outcome(s)
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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.
[Time Frame: week 4]
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Secondary Outcome(s)
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Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as nightly pain, heartburn, nightly acid regurgitation, nausea & vomiting, eructation, and increased flatus.
[Time Frame: week 4]
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Secondary ID(s)
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2005L02943
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Livzon-IY-81149-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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