Status:
COMPLETED
Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
Janssen Korea, Ltd., Korea
Conditions:
Early Gastric Adenocarcinoma
Adenocarcinoma, Tubular
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
Detailed Description
* Endoscopic mucosal resection (EMR) is less invasive than surgery and is known to be general treatment for early gastric cancer or gastric adenoma when patients' quality of life is taken into conside...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Patients with esophageal ulcer, stricture, or obstruction
- Patients who have pacemaker or implantable cardiac defibrillator in place
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00844675
Start Date
October 1 2007
End Date
March 1 2012
Last Update
October 18 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Catholic University, Gangnam St. Mary's Hospital
Seoul, Ban-po Dong 505, South Korea, 137-040