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Phase 4 N=301 Randomized Double-blind Treatment

Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer

Stomach Ulcer

Enrolled (actual)
301
Serious AEs
1.0%
Results posted
Jun 2021
Primary outcome: Primary: Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8 — 70.13; 60.54 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Rebamipide (Drug)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Primary completion
Sep 2005

Outcome Measures

OutcomeResultp-value
PRIMARY
Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
70.13; 60.54

Summary

To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study

Eligibility Criteria

Inclusion Criteria

  • Patients aged 20 years or older at time of consent
  • H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent
  • Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification), • Solitary, • Longitudinal diameter: ->5 mm
  • Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy

Exclusion Criteria

  • Patients who have previously received H. pylori eradication therapy
  • Patients with acute gastric ulcer
  • Patients with linear ulcer
  • Patients with complication of duodenal ulcer (excluding cicatrix)
  • Patients who have undergone upper-GI tract or vagal nerve resection
  • Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
  • Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
  • Patients with a history of amoxicillin shock
  • Patients with infectious mononucleosis
  • Patients with severe renal disorders
  • Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
  • Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
  • Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
  • Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00233389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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