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Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers

Primary Purpose

Peptic Ulcer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
histamine-2 receptor antagonist group
proton pump inhibitor group
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peptic Ulcer focused on measuring histamine-2 receptor antagonist, proton pump inhibitor, thienopyridine, clopidogrel, prevention

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers).
  • Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination.
  • Subjects have received thienopyridine therapy for at least two weeks.
  • Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases.

Exclusion Criteria:

  • A history of gastric or duodenal surgery other than oversewing of a perforation.
  • Subjects who are allergic to the study drugs.
  • Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents.
  • Pregnancy.
  • Subjects who have active cancer, acute serious medical illness or terminal illness.
  • Subjects who have gastroesophageal reflux disease.

Sites / Locations

  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

proton pump inhibitor group

histamine-2 receptor antagonist group

Arm Description

Pantoprazole Tab 40mg qd for 6 monthrs.

famotidine Tab 40 mg qd for 6 months.

Outcomes

Primary Outcome Measures

Number of Participants With Ulcer Recurrence
Follow-up endoscopy was performed at the end of the 6th month

Secondary Outcome Measures

Full Information

First Posted
September 14, 2015
Last Updated
June 24, 2019
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT02551744
Brief Title
Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers
Official Title
Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users - a Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.
Detailed Description
The aims of the randomized double-blind comparison study are to compare the efficacy of Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40 mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer
Keywords
histamine-2 receptor antagonist, proton pump inhibitor, thienopyridine, clopidogrel, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proton pump inhibitor group
Arm Type
Active Comparator
Arm Description
Pantoprazole Tab 40mg qd for 6 monthrs.
Arm Title
histamine-2 receptor antagonist group
Arm Type
Experimental
Arm Description
famotidine Tab 40 mg qd for 6 months.
Intervention Type
Drug
Intervention Name(s)
histamine-2 receptor antagonist group
Other Intervention Name(s)
famotidine 40 mg
Intervention Description
famotidine tab 40 mg qd for 6 months.
Intervention Type
Drug
Intervention Name(s)
proton pump inhibitor group
Other Intervention Name(s)
pantoprazole 40mg
Intervention Description
pantoprazole tab 40 mg qd for 6 months.
Primary Outcome Measure Information:
Title
Number of Participants With Ulcer Recurrence
Description
Follow-up endoscopy was performed at the end of the 6th month
Time Frame
six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers). Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination. Subjects have received thienopyridine therapy for at least two weeks. Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases. Exclusion Criteria: A history of gastric or duodenal surgery other than oversewing of a perforation. Subjects who are allergic to the study drugs. Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents. Pregnancy. Subjects who have active cancer, acute serious medical illness or terminal illness. Subjects who have gastroesophageal reflux disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-I Hus, Bachelor
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

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Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers

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