Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection - Full Text View

Sponsor:	The Catholic University of Korea
Collaborator:	Janssen Korea, Ltd., Korea
Information provided by:	The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT00844675

Purpose

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

Condition	Intervention	Phase
Early Gastric Adenocarcinoma Adenocarcinoma, Tubular	Drug: rabeprazole Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Preoperative Administration of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection(EMR): Prospective, Randomized, Placebo-Controlled, Comparative Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: E 3810

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:

Frequency of bleeding after EMR is performed [ Time Frame: 4weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number (No./cm2) of visible vessels on the fundus of ulcer on endoscopy performed within 24 hours after EMR [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
Percentage of a pH change with intragastric pH greater than 6 in 24 hours after EMR [ Time Frame: day 0 ] [ Designated as safety issue: No ]
Measurement of a change in the size of ulcer [ Time Frame: 4weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
rabeprazole: Experimental rabeprazole	Drug: rabeprazole 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).
placebo: Experimental placebo	Drug: placebo 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).

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 consideration. However, major complications such as bleeding and perforation remain to be problematic.1-5 The incidence of these complications is expected to rise as the size of lesions for which EMR is indicated has enlarged. Histamine 2 receptor antagonists (H2RA) and proton pump inhibitors (PPI) have been used for the bleeding,1-3 but the bleeding rate following EMR has been reported to be still high as 1.4% to 24%.1,4 Green et al and Berstad et al cited in their research that intragastric PH should be sustained above 5.4 to prevent bleeding, and PPIs should be administered instead of H2RAs to keep PH above 5.4. Being studied are administration modalities to enhance the therapeutic efficacy of PPIs or H2RAs.1-3 Several studies have already demonstrated that high-dose PPI therapy, for which a PPI was administered twice daily, effectively blocks acid secretion by increasing intragastric pH to neutral.3 Our study team also suggested in a previous study that high-dose PPI therapy was adequate to maintain intragastric pH above 6.
PPIs are known to induce the suppression of acid secretion because they destroy a proton pump, yet it takes 5 days to achieve their maximum effects.7,8 It's been suggested that the onset of PPIs is slow to prevent bleeding with administration of a PPI after EMR.4 Therefore, our investigators expect that 5-day administration of an oral PPI before EMR would increase intragastric pH to above 6 and would be at least equal to or superior to intravenous PPIs currently being used in terms of the suppression of acid secretion.
This is a prospective, randomized, comparative study to substantiate that oral administration of rabeprazole (Pariet tablets) 20mg twice daily before and after EMR (PO RBP group) will show similar effects on the prevention of bleeding compared with the conventional treatment with iv administration of pantoprazole after EMR but no special medication given before EMR (Placebo group). In addition, we are going to measure intragastric pH among part of study subjects and then to evaluate if the effect of acid suppression in the PO RBP group is superior to that in the placebo group.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844675

Contacts

Contact: Choi Myung-gui, professor

82-2-590-2471

choim@catholic.ac.kr

Locations

Korea, Republic of, Ban-po dong 505
Catholic University, Gangnam St. Mary's Hospital	Recruiting
Seoul, Ban-po dong 505, Korea, Republic of, 137-040
Contact: Choi Myung-gui, Professor 82-2-590-2471 choim@catholic.ac.kr
Principal Investigator: Choi Myung-gui, Professor

Sponsors and Collaborators

The Catholic University of Korea

Janssen Korea, Ltd., Korea

Investigators

Principal Investigator:

MyungKu Choi, MD

The Catholic University of Korea

More Information

No publications provided

Responsible Party:	The Catholic University of Korea ( Choi, Myung-Gyu )
Study ID Numbers:	RAB-KOR-9035
Study First Received:	February 13, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00844675 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by The Catholic University of Korea:

endoscopic mucosal resection
Proton Pump Inhibitor
gastrointestinal hemorrhage
rabeprazole

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Anti-Ulcer Agents
Gastrointestinal Neoplasms
Adenocarcinoma
Rabeprazole
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010