Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rebamipide 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). Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks |
Drug: Rebamipide
Brand name: Mucosta® Tab.
Generic name: Rebamipide.
Chemical name:
(±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]propionic acid.
Formulation: Tablet (White, film-coated tablet).
Strength: One tablet contains rebamipide 100mg.
Storage condition: 15℃~25℃.
Manufacturer: Korea Otsuka Pharmaceuticals
Other Names:
|
| Active Comparator: Omeprazole 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) Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks |
Drug: Omeprazole
Brand name: Losec® Cap.
Generic name: Omeprazole.
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Gastric ulcer healing rate [at 12 weeks after the initial administration of the study medication]
Rebamipide showed 81.5~87.8% of gastric ulcer healing rate which was not inferior to 82.5~87.8% healing rate of Omeprazole.
Secondary Outcome Measures
- Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.) [at 12 weeks after the initial administration of the study medication]
- Serum gastrin level [at 8 and 12 weeks after the initial administration of study medication]
- Economical efficiency [drug cost/effect ratio]
Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged 20 or older at the time of writing the informed consent
-
- pylori-positive patient.
-
Patients who are diagnosed with gastric ulcer by endoscopy and have the following ulcer characteristics; Non-scarring ulcer (stage A1, A2, H1, H2 according to the Sakita-Miwa classification), Single ulcer, Ulcer size of 5 to 20mm in diameter
Exclusion Criteria:
-
Patients who previously underwent H. pylori eradication therapy
-
Malignant gastric ulcer
-
Linear ulcer
-
Patients with history of upper GI tract resection or vagotomy
-
Patients with continuous NSAIDs use within 4 weeks prior to study initiation
-
Patients with ulcer complications including perforation or pyloric stenosis
-
Gastric ulcer prone to bleeding (e.g. exposed blood vessels at ulcer base)
-
Patients with infectious mononucleosis
-
Patients with known hypersensitivity to penicillin, clarithromycin, omeprazole, amoxicillin or rebamipide
-
Patients on medications such as terfenadine or pimozide which are contraindicated with clarithromycin usage
-
Pregnant or possibly pregnant women, lactating women, or those with a plan to conceive during this study
-
Blood test results of Hb ≤ 8.0 g/dl, platelet ≤50,000 /㎕, total WBC ≤ 4000/㎕ or ≥ 10,000/㎕, and with serum test results showing the levels of AST, ALT, ALP, LDH, BUN, and creatinine exceeding twice the normal range of respective institution.
-
Other patients deemed not eligible for this study by investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The 1st Affiliated hospital - Zhongshan Univ. | Guangzhou | Guangdong | China | 510080 |
| 2 | Nanfang Hospital - Nanfang Medical Univ. | Guangzhou | Guangdong | China | 510515 |
| 3 | Xijing Hospital - The 4th Military Medical Univ | Xi'An | Shanxi | China | 710032 |
| 4 | The 1st Affiliated Hospital - Medical School of Zhejiang Univ. | Hangzhou | Zhejiang | China | 310003 |
| 5 | Ren-Ji Hospital - Shanghai Second Medical Univ. | Shanghai | China | 200001 | |
| 6 | Korea University Ansan Hospital | Ansan | Korea, Republic of | 425-707 | |
| 7 | Severance Hospital, Seoul National University | Seoul | Korea, Republic of | 120-752 |
Sponsors and Collaborators
- Korea Otsuka International Asia Arab
- Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Jin-Ho Kim, M.D., Asan Medical Center, Ulsan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OIAAMCTIVK205