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NCT Number: NCT00272467

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

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.

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Key information

Conditions

Stomach Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanfang Hospital - Nanfang Medical Univ., Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rebamipide

Drug
  • 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: Mucosta

Omeprazole

Drug
  • 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: Losec

Primary outcomes

  1. Gastric ulcer healing rate

    Time frame: 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 outcomes

  1. 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

  2. Serum gastrin level

    Time frame: at 8 and 12 weeks after the initial administration of study medication

  3. Economical efficiency

    Time frame: drug cost/effect ratio

    Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.

Sponsors and collaborators

Lead sponsor

Korea Otsuka International Asia Arab

Industry

Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.
  • Zhejiang Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 6, 2006
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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