The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer

March 25, 2019 updated by: Yonsei University
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Several procedure-related complications may occur after ESD. Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are administered after ESD. In addition, ulcer protective agents such as rebamipide can be added to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

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

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

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age, between 19 and 79
  2. Patients with gastric adenoma or early gastric cancer
  3. Patients with ECOG-PS 0 or 1
  4. Patients with adequate renal function
  5. Patients with adequate hepatic function
  6. Patients with adequate bone marrow function

Exclusion Criteria:

  1. Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD.
  2. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD.
  3. Patients who has undergone gastrostomy
  4. Patients with allergy for pantoprazole, polaprezinc, or rebamipide.
  5. Pregnant or breast feeding.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rebamipide group
Drug: Rebamipide
Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
Active Comparator: Polaprezinc group
Drug: Polaprezinc
Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcering healing rate
Time Frame: 4 weeks after the ESD
Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
4 weeks after the ESD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scarring change rate
Time Frame: 4 weeks after the ESD
Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
4 weeks after the ESD

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (Actual)

January 14, 2015

Primary Completion (Actual)

April 14, 2016

Study Completion (Actual)

April 14, 2016

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 18, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0381

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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