Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)
Information source: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Duodenal Ulcer
Intervention: 5 mg ilaprazole (Drug); 10 mg ilaprazole (Drug); 20 mg ilaprazole (Drug); 20 mg omeprazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Livzon Pharmaceutical Group Inc. Official(s) and/or principal investigator(s): S R Lin, M.D, Principal Investigator, Affiliation: Peking University Third Hospital
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.
Clinical Details
Official title: Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase2 Trial in China
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus.
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 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 stages and S2 stage is better than S1. Healing
of ulcer is deemed successful if an ulcer in A stage resolved to S stage at the end of the
treatment period, regardless of S1 or S2. When endoscopy demonstrated successful ulcer
healing, study medication was discontinued. Patients returned at week 2, and if unhealed
further endoscopic assessment would be done at week 4. Secondary endpoints included
post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain,
heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus. These
symptoms were recorded on a scale ranging from 0 to 3(0=none, 1=mild, 2=moderate, 3=severe)
at baseline, week 1, 2, and 4. Resolution of symptoms were defined as "excellence",
"effective", "improved", or "ineffective" relative to baseline levels, of which complete
symptom relief or complete absence of the symptom without recurrence was deemed as
"excellence". Safety assessments based mainly on the occurrence, frequency, and severity of
adverse events, which were monitored throughout the duration of the study, and also based on
comprehensive indexes, including physical examination, electrocardiography, and routine
laboratory investigations, which were performed at baseline and repeated at the end of the
treatment period. For all adverse events, where necessary, patients were withdrawn from the
study.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Peking University Third Hospital, Beijing, Beijing, China
Additional Information
Starting date: October 2004
Last updated: August 5, 2009
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