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

Stomach Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233389
• Other study ID #: C03700-003
• Secondary ID: JapicCTI-050035
• Status: Completed
• Phase: Phase 4
• Start date: April 30, 2004
• Est. completion date: September 9, 2005

Study information

• Verified date: May 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: September 9, 2005
• Est. primary completion date: September 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 20 years or older at time of consent

2. 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

3. Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification), • Solitary, • Longitudinal diameter: ->5 mm

4. Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy

Exclusion 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 Conditions & MeSH terms

• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Rebamipide

Locations

Country	Name	City	State
Japan	Otsuka Pharmaceutical Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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