NCT00272467

Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy

A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Korea Otsuka International Asia Arab · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stomach Ulcer

Interventions

Type	Name	Description
DRUG	Rebamipide	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
DRUG	Omeprazole	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.

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-01-06
• Last updated: 2015-04-29

Locations

7 sites across 2 countries: China, South Korea