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

NCT02551744 | Completed Results DMC

• 1 other identifier: VGHKS12-CT7-08
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peptic Ulcer

Keywords

histamine-2 receptor antagonist; proton pump inhibitor; thienopyridine; clopidogrel; prevention

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ulcer Recurrence

  Follow-up endoscopy was performed at the end of the 6th month

  six month

Study Arms (2)

proton pump inhibitor group

ACTIVE COMPARATOR

Pantoprazole Tab 40mg qd for 6 monthrs.

Drug: proton pump inhibitor group

histamine-2 receptor antagonist group

EXPERIMENTAL

famotidine Tab 40 mg qd for 6 months.

Drug: histamine-2 receptor antagonist group

Interventions

histamine-2 receptor antagonist group DRUG

famotidine tab 40 mg qd for 6 months.

Also known as: famotidine 40 mg

histamine-2 receptor antagonist group

proton pump inhibitor group DRUG

pantoprazole tab 40 mg qd for 6 months.

Also known as: pantoprazole 40mg

proton pump inhibitor group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (21)

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• CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.

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• Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7.

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MeSH Terms

Conditions

Peptic Ulcer

Interventions

Famotidine; Pantoprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The trial was performed in a single country

Results Point of Contact

• Title: Dr. Ping-I Hsu
• Organization: Kaohsiung Veterans General Hospital

pihsu@vghks.gov.tw

+886-7-3422121

Study Officials

• Ping-I Hus, Bachelor

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 16, 2015
• Study Start: July 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Locations

TW (1)