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

NCT00233389 | Completed Phase 4 Results

• 2 other identifiers: C03700-003JapicCTI-050035
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stomach Ulcer

Outcome Measures

Primary Outcomes (1)

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

  Week 8

Interventions

Rebamipide DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

rebamipide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

  Division of New Product Evaluation and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: April 30, 2004
• Primary Completion: September 1, 2005
• Study Completion: September 9, 2005
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-05

Locations

JP (1)