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

NCT00844675 | Completed Phase 4

• 1 other identifier: RAB-KOR-9035
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Early Gastric Adenocarcinoma; Adenocarcinoma, Tubular

Keywords

endoscopic mucosal resection; Proton Pump Inhibitor; gastrointestinal hemorrhage; rabeprazole

Outcome Measures

Primary Outcomes (1)

• Frequency of bleeding after EMR is performed

  4weeks

Secondary Outcomes (3)

• Number (No./cm2) of visible vessels on the fundus of ulcer on endoscopy performed within 24 hours after EMR

  day 1

• Percentage of a pH change with intragastric pH greater than 6 in 24 hours after EMR

  day 0

• Measurement of a change in the size of ulcer

  4weeks

Study Arms (2)

rabeprazole

EXPERIMENTAL

rabeprazole

Drug: rabeprazole

placebo

EXPERIMENTAL

placebo

Drug: placebo

Interventions

rabeprazole DRUG

The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

Also known as: Pariet(rabeprazole)

rabeprazole

placebo DRUG

The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Gastric adenoma
• 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)
• 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

You may not qualify if:

• Patients who meet the criteria described below should be excluded from study subjects:
• Younger than 18 years old
• Patients with a history of upper gastrointestinal surgery or vagotomy
• 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)
• Patients with diseases that may have a great impact on the clinical study
• Patients to whom the stimulation of gastrointestinal movement poses risks as in gastrointestinal bleeding, mechanical ileus and perforation
• Women who are pregnant or nursing
• Patients who are being treated with adrenocorticoid steroids, nonsteroidal anti-inflammatory drugs including aspirin, or other ulcer inducers
• 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)
• Patients with severe psychiatric diseases
• 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
• Patients who did not consent to the clinical study
• Patients who can not be examined
• Patients with bleeding tendency
• Patients with esophageal varices

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Janssen Korea, Ltd., Korea: collaborator

Study Sites (1)

Catholic University, Gangnam St. Mary's Hospital

Seoul, Ban-po Dong 505, 137-040, South Korea

Location

MeSH Terms

Conditions

Adenocarcinoma; Gastrointestinal Hemorrhage

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• MyungKu Choi, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

KR (1)