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

Primary Purpose

Stomach Ulcer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rebamipide
Omeprazole
Sponsored by
Korea Otsuka International Asia Arab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Ulcer focused on measuring Helicobacter pylori, Stomach ulcer, Rebamipide, Omeprazole

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 1st Affiliated hospital - Zhongshan Univ.
  • Nanfang Hospital - Nanfang Medical Univ.
  • Xijing Hospital - The 4th Military Medical Univ
  • The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
  • Ren-Ji Hospital - Shanghai Second Medical Univ.
  • Korea University Ansan Hospital
  • Severance Hospital, Seoul National University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rebamipide

Omeprazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.)
Serum gastrin level
Economical efficiency
Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.

Full Information

First Posted
January 4, 2006
Last Updated
April 27, 2015
Sponsor
Korea Otsuka International Asia Arab
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd., Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00272467
Brief Title
Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Official Title
A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka International Asia Arab
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd., Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer
Keywords
Helicobacter pylori, Stomach ulcer, Rebamipide, Omeprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rebamipide
Arm Type
Experimental
Arm Description
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
Arm Title
Omeprazole
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Other Intervention Name(s)
Mucosta
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Losec
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastric ulcer healing rate
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Serum gastrin level
Time Frame
at 8 and 12 weeks after the initial administration of study medication
Title
Economical efficiency
Description
Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.
Time Frame
drug cost/effect ratio

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Ho Kim, M.D.
Organizational Affiliation
Asan Medical Center, Ulsan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated hospital - Zhongshan Univ.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital - Nanfang Medical Univ.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Xijing Hospital - The 4th Military Medical Univ
City
Xi'An
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Ren-Ji Hospital - Shanghai Second Medical Univ.
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Korea University Ansan Hospital
City
Ansan
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Severance Hospital, Seoul National University
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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