CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 301 enrolled
Drug / intervention
Rebamipidedrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study, AND H. pylori-antibody-positive by urine-based test after consent
  • ✓Endoscopically confirmed active gastric ulcer (A1 or A2 stage by Sakita/Miwa classification), solitary, longitudinal diameter ≥5 mm
  • ✓Age ≥20 years at consent
  • ✓No PPIs, antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy
Key exclusion· 11
  • ✕Prior H. pylori eradication therapy
  • ✕Acute gastric ulcer or linear ulcer
  • ✕Complication of duodenal ulcer (excluding cicatrix)
  • ✕Prior upper-GI tract or vagal nerve resection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233389
NCT00233389Phase 4Completed
CompareCT.gov

A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 5, 2005·Updated Jun 4, 2021

In Brief

A Phase 4 clinical trial evaluating Rebamipide for Stomach Ulcer. Completed, enrolled 301 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStomach Ulcer
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartApr 30, 2004
Primary CompletionSep 1, 2005
Study CompletionSep 9, 2005
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.7 years ago

Interventions

Rebamipidedrug