A Phase 3 interventional study of 10 mg ilaprazole and 20 mg omeprazole in Duodenal Ulcer, sponsored by Livzon Pharmaceutical Group Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-08-06.
Sponsored by Livzon Pharmaceutical Group Inc. · Phase 3, Interventional, and Treatment
Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four weeks and be seen at week 1, 2 and 4. 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.
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.
75 studies on the registry are indexed under Duodenal Ulcer; 5 are open to participants now.
This study's enrollment of 496 is above the median of 284 across 50 interventional studies indexed under Duodenal Ulcer.
Browse Duodenal Ulcer studies →Livzon Pharmaceutical Group Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
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Consenting patients were eligible for enrollment if they:
Exclusion Criteria:
Patients were ineligible if they:
Drug: 10 mg ilaprazole
Drug: 20 mg omeprazole
Two 5-mg ilaprazole tablets(Livzon Pharm Group Inc., China) together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
One 20-mg omeprazole capsule (AstraZeneca, Losec) together with two placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks
Also known as: Losec,AstraZeneca
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
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
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Livzon Pharmaceutical Group Inc.