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Completed

NCT Number: NCT00233389

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

rebamipide

Drug

Primary outcomes

  1. Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8

    Time frame: Week 8

    The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 5, 2005
Registry last updated
Jun 4, 2021

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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