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

Stomach Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272467
• Other study ID #: OIAAMCTIVK205
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2006
• Last updated: April 27, 2015
• Start date: July 2005
• Est. completion date: April 2008

Study information

• Verified date: April 2015
• Source: Korea Otsuka International Asia Arab
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 20 or older at the time of writing the informed consent

• H. 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Ulcer
• Ulcer

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital - Nanfang Medical Univ.	Guangzhou	Guangdong
China	The 1st Affiliated hospital - Zhongshan Univ.	Guangzhou	Guangdong
China	The 1st Affiliated Hospital - Medical School of Zhejiang Univ.	Hangzhou	Zhejiang
China	Ren-Ji Hospital - Shanghai Second Medical Univ.	Shanghai
China	Xijing Hospital - The 4th Military Medical Univ	Xi'An	Shanxi
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Severance Hospital, Seoul National University	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Korea Otsuka International Asia Arab	Korea Otsuka Pharmaceutical Co.,Ltd., Zhejiang Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 12 weeks after the initial administration of the study medication	No
Secondary	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	No
Secondary	Serum gastrin level		at 8 and 12 weeks after the initial administration of study medication	No
Secondary	Economical efficiency	Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.	drug cost/effect ratio	No