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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.

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 16, 2015
Results First Submitted Date  ICMJE October 30, 2018
Results First Posted Date  ICMJE August 8, 2019
Last Update Posted Date August 8, 2019
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Number of Participants With Ulcer Recurrence [ Time Frame: six month ]
Follow-up endoscopy was performed at the end of the 6th month
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
Ulcer recurrence rate [ Time Frame: six month ]
Change History Complete list of historical versions of study NCT02551744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers
Official Title  ICMJE Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users — a Double-blind Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Peptic Ulcer
Intervention  ICMJE
  • Drug: histamine-2 receptor antagonist group
    famotidine tab 40 mg qd for 6 months.
    Other Name: famotidine 40 mg
  • Drug: proton pump inhibitor group
    pantoprazole tab 40 mg qd for 6 months.
    Other Name: pantoprazole 40mg
Study Arms  ICMJE
  • Active Comparator: proton pump inhibitor group
    Pantoprazole Tab 40mg qd for 6 monthrs.
    Intervention: Drug: proton pump inhibitor group
  • Experimental: histamine-2 receptor antagonist group
    famotidine Tab 40 mg qd for 6 months.
    Intervention: Drug: histamine-2 receptor antagonist group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019)
101
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2015)
334
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02551744
Other Study ID Numbers  ICMJE VGHKS12-CT7-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ping-I Hus, Bachelor Kaohsiung Veterans General Hospital.
PRS Account Kaohsiung Veterans General Hospital.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP