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

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ClinicalTrials.gov Identifier: NCT02243618
Recruitment Status : Completed
First Posted : September 18, 2014
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Adenoma Early Gastric Cancer Drug: Polaprezinc Drug: Rebamipide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 14, 2015
Actual Primary Completion Date : April 14, 2016
Actual Study Completion Date : April 14, 2016

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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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243618


Locations
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Korea, Republic of
Sevrance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02243618    
Other Study ID Numbers: 4-2014-0381
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: December 2016
Additional relevant MeSH terms:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rebamipide
Polaprezinc
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors