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

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ClinicalTrials.gov Identifier: NCT02551744
Recruitment Status : Completed
First Posted : September 16, 2015
Results First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:
Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: histamine-2 receptor antagonist group Drug: proton pump inhibitor group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users — a Double-blind Randomized Controlled Trial
Study Start Date : July 2012
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Active Comparator: proton pump inhibitor group
Pantoprazole Tab 40mg qd for 6 monthrs.
Drug: proton pump inhibitor group
pantoprazole tab 40 mg qd for 6 months.
Other Name: pantoprazole 40mg

Experimental: histamine-2 receptor antagonist group
famotidine Tab 40 mg qd for 6 months.
Drug: histamine-2 receptor antagonist group
famotidine tab 40 mg qd for 6 months.
Other Name: famotidine 40 mg




Primary Outcome Measures :
  1. Number of Participants With Ulcer Recurrence [ Time Frame: six month ]
    Follow-up endoscopy was performed at the end of the 6th month



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02551744


Locations
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Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Study Chair: Ping-I Hus, Bachelor Kaohsiung Veterans General Hospital.
  Study Documents (Full-Text)

Documents provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
Study Protocol  [PDF] July 31, 2018
No Statistical Analysis Plan (SAP) exists for this study.


Publications:

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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02551744     History of Changes
Other Study ID Numbers: VGHKS12-CT7-08
First Posted: September 16, 2015    Key Record Dates
Results First Posted: August 8, 2019
Last Update Posted: August 8, 2019
Last Verified: June 2019
Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
histamine-2 receptor antagonist
proton pump inhibitor
thienopyridine
clopidogrel
prevention
Additional relevant MeSH terms:
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Famotidine
Peptic Ulcer
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pantoprazole
Proton Pump Inhibitors
Histamine
Histamine phosphate
Histamine H2 Antagonists
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Histamine Antagonists