Phase 4
N=301
Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
Stomach Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00233389 ↗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
| Outcome | Result | p-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
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.