Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is:

• To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects of ulcer bleeding compared with placebo group (preoperative administration of placebo)

• To evaluate the effects on the suppression of acid secretion of preoperative administration of an Proton pump inhibitor

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborator: Janssen Korea, Ltd., Korea
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• Patients who have EMR planned as well as meet the criteria described below will be selected as study subjects

• Patients in whom EMR is indicated:

1. Gastric adenoma

2. Early gastric adenocarcinoma

• Moderately or well differentiated adenocarcinoma

• Gastric cancer limited to only mucosa on endoscopic ultrasonography

• No invasion of lymph nodes or metastases (diagnosed by CT)

3. EMR to be performed for other diagnostic purposes

• Women of child-bearing potential should avoid pregnancy

• Subjects who consented to a EMR procedure in writing

Exclusion Criteria:

• Patients who meet the criteria described below should be excluded from study subjects:

1. Younger than 18 years old

2. Patients with a history of upper gastrointestinal surgery or vagotomy

3. Patients with serious adverse reactions secondary to cardiac, renal, hepatic, or hematologic diseases (e.g. creatinine> 2.5 mg/dl, total bilirubin >3.0 mg/dl)

4. Patients with diseases that may have a great impact on the clinical study

5. Patients to whom the stimulation of gastrointestinal movement poses risks as in gastrointestinal bleeding, mechanical ileus and perforation

6. Women who are pregnant or nursing

7. Patients who are being treated with adrenocorticoid steroids, nonsteroidal anti-inflammatory drugs including aspirin, or other ulcer inducers

8. Patients who are taking other antiulcer drugs (antacids, antihistamines, etc) that may affect the efficacy assessments of the study drug (but, except for patients not taking the drugs over 7 days)

9. Patients with severe psychiatric diseases

10. Patients who received other investigational drugs within 30 days prior to the start of this study or who are currently participating in other clinical study

11. Patients who did not consent to the clinical study

12. Patients who can not be examined

• Patients with bleeding tendency

• Patients with esophageal varices

• Patients with esophageal ulcer, stricture, or obstruction

• Patients who have pacemaker or implantable cardiac defibrillator in place