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Trial record 40 of 69 for:    Famotidine

Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

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ClinicalTrials.gov Identifier: NCT02418312
Recruitment Status : Completed
First Posted : April 16, 2015
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:
Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: histamine-2 receptor antagonist Drug: Placebo Not Applicable

Detailed Description:
The aim of the prospective, randomized study is investigate the efficacy of H2 receptor antagonist in prevention of thienopyridine-related peptic ulcer and gastrointestinal bleeding in patients with an ulcer history. We plan to enroll 236 thienopyridine (clopidogrel or ticlopidine) users with a peptic ulcer history who don't have baseline gastroduodenal ulcers at initial endoscopy . The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months. The ulcer recurrence rate between the treatment gruops will be compared.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer
Study Start Date : January 2012
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

Arm Intervention/treatment
Active Comparator: histamine-2 receptor antagonist group
famotidine 40mg qd for 6 months.
Drug: histamine-2 receptor antagonist
famotidine 40 mg qd plus thienopyridine
Other Name: famotidine 40 mg qd

Placebo Comparator: placebo group
placebo for 6 months.
Drug: Placebo
placebo plus thienopyridine




Primary Outcome Measures :
  1. Number of Participants With Healed Peptic Ulcer [ Time Frame: 6 months ]
    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:

  1. The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms.
  2. thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy.
  3. They are adult patients aged least 20 years of age.

Exclusion Criteria:

  1. They have a history of gastric or duodenal surgery other than oversewing of a perforation.
  2. They require long-term treatment with non-steroidal anti-inflammatory drugs.
  3. serious 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): NCT02418312


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 Hsu, Bachelor Kaohsiung Veterans General Hospital.
  Study Documents (Full-Text)

Documents provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:

Publications:

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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02418312     History of Changes
Other Study ID Numbers: VGHKS11-CT12-10
First Posted: April 16, 2015    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
histamine-2 receptor antagonist
peptic ulcer
thienopyridine
prevention

Additional relevant MeSH terms:
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Famotidine
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Histamine
Histamine phosphate
Histamine H2 Antagonists
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine Antagonists