A Phase 4 interventional study of Rebamipide and Omeprazole in Stomach Ulcer, sponsored by Korea Otsuka International Asia Arab. Completed at 7 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by Korea Otsuka International Asia Arab · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy.
This study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known PPI, omeprazole. This is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. This study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's enrollment of 132 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →Korea Otsuka International Asia Arab is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) Rebamipide 100mg, t.i.d. (before breakfast, evening, before bed). 2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks
Drug: Rebamipide
1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) omeprazole 20mg, once daily (before breakfast) 2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks
Drug: Omeprazole
1. Brand name: Mucosta® Tab. 2. Generic name: Rebamipide. 3. Chemical name: (±)-2-(4-chlorobenzoylamino)-3-\[2(1H)-quinolinon-4-yl\]propionic acid. 4. Formulation: Tablet (White, film-coated tablet). 5. Strength: One tablet contains rebamipide 100mg. 6. Storage condition: 15℃\~25℃. 7. Manufacturer: Korea Otsuka Pharmaceuticals
Also known as: Mucosta
1. Brand name: Losec® Cap. 2. Generic name: Omeprazole. 3. Chemical name: 5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃\~25℃. 7) Manufacturer: AstraZenaca Korea.
Also known as: Losec
Gastric ulcer healing rate
Rebamipide showed 81.5\~87.8% of gastric ulcer healing rate which was not inferior to 82.5\~87.8% healing rate of Omeprazole.
Time frame: at 12 weeks after the initial administration of the study medication
Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
Time frame: at 12 weeks after the initial administration of the study medication
Serum gastrin level
Time frame: at 8 and 12 weeks after the initial administration of study medication
Economical efficiency
Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.
Time frame: drug cost/effect ratio
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Korea Otsuka International Asia Arab