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

October 16, 2012 updated by: Myung-gui Choi, The Catholic University of Korea

Effects of Preoperative Administration of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection(EMR): Prospective, Randomized, Placebo-controlled, Comparative Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Ban-po dong 505
      • Seoul, Ban-po dong 505, Korea, Republic of, 137-040
        • Catholic University, Gangnam St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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).
Other Names:
  • Pariet(rabeprazole)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Frequency of bleeding after EMR is performed
Time Frame: 4weeks
4weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number (No./cm2) of visible vessels on the fundus of ulcer on endoscopy performed within 24 hours after EMR
Time Frame: day 1
day 1
Percentage of a pH change with intragastric pH greater than 6 in 24 hours after EMR
Time Frame: day 0
day 0
Measurement of a change in the size of ulcer
Time Frame: 4weeks
4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Catholic University of Korea

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Korea, Ltd., Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MyungKu Choi, MD, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RAB-KOR-9035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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