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

JRCT ID: jRCT1080220035

Registered date:06/09/2005

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Gastric ulcer
• Date of first enrollment: 30/04/2004
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Rebamipide
INN of investigational material : Rebamipide
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome

safety
efficacy
Efficacy/safety

• Secondary Outcome: -

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who are H pylori positive and have active gastric ulcer, and aged 20 yeas or older at time of concent

Exclude criteria

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

Related Information

• Primary Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT00233389,JapicCTI-050035