Peptic UlcerNCT02551744

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

A study testing histamine-2 receptor antagonist group and proton pump inhibitor group in people with Peptic Ulcer, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear. Read more about this study

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Peptic Ulcer
What is being tested?: histamine-2 receptor antagonist group and proton pump inhibitor group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 1 siteTaiwan
Study dates: Jul 2012to Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Kaohsiung Veterans General Hospital
Kaohsiung City, 813

Other trials in Taiwan

About this study

Official title: Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users - a Double-blind Randomized Controlled Trial

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

Read the 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.

Conditions: Peptic Ulcer
Being tested: histamine-2 receptor antagonist group, proton pump inhibitor group
Keywords: histamine-2 receptor antagonist, proton pump inhibitor, thienopyridine, clopidogrel, prevention
Medical subject headings: Peptic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

histamine-2 receptor antagonist groupDrug
Also called famotidine 40 mg
famotidine tab 40 mg qd for 6 months.
proton pump inhibitor groupDrug
Also called pantoprazole 40mg
pantoprazole tab 40 mg qd for 6 months.

Study groups in NCT02551744
Study group	Role	What they receive
proton pump inhibitor group	Active comparator	Pantoprazole Tab 40mg qd for 6 monthrs. Receives: Drug: proton pump inhibitor group
histamine-2 receptor antagonist group	Experimental	famotidine Tab 40 mg qd for 6 months. Receives: Drug: histamine-2 receptor antagonist group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jul 2018

First posted16 Sep 2015 (estimated)
Study startJul 2012
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Peptic UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02551744
Sponsor's protocol ID: VGHKS12-CT7-08
Status last verified: Jun 2019
First submitted: 14 Sep 2015
Last updated: 8 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Savi P, Nurden P, Nurden AT, Levy-Toledano S, Herbert JM. Clopidogrel: a review of its mechanism of action. Platelets. 1998;9(3-4):251-5. doi: 10.1080/09537109876799.
PubMed 16793712
Boeynaems JM, van Giezen H, Savi P, Herbert JM. P2Y receptor antagonists in thrombosis. Curr Opin Investig Drugs. 2005 Mar;6(3):275-82.
PubMed 15816504
Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
PubMed 11519503
Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
PubMed 16531616
Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.
PubMed 11520521
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.
PubMed 8918275
Fork FT, Lafolie P, Toth E, Lindgarde F. Gastroduodenal tolerance of 75 mg clopidogrel versus 325 mg aspirin in healthy volunteers. A gastroscopic study. Scand J Gastroenterol. 2000 May;35(5):464-9. doi: 10.1080/003655200750023705.
PubMed 10868447
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.
PubMed 21144850
Chan FK, Ching JY, Hung LC, Wong VW, Leung VK, Kung NN, Hui AJ, Wu JC, Leung WK, Lee VW, Lee KK, Lee YT, Lau JY, To KF, Chan HL, Chung SC, Sung JJ. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005 Jan 20;352(3):238-44. doi: 10.1056/NEJMoa042087.
PubMed 15659723
Ma L, Elliott SN, Cirino G, Buret A, Ignarro LJ, Wallace JL. Platelets modulate gastric ulcer healing: role of endostatin and vascular endothelial growth factor release. Proc Natl Acad Sci U S A. 2001 May 22;98(11):6470-5. doi: 10.1073/pnas.111150798. Epub 2001 May 15.
PubMed 11353854
Laine L, Maller ES, Yu C, Quan H, Simon T. Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: a double-blind trial. Gastroenterology. 2004 Aug;127(2):395-402. doi: 10.1053/j.gastro.2004.05.001.
PubMed 15300570
Ng FH, Wong SY, Lam KF, Chu WM, Chan P, Ling YH, Kng C, Yuen WC, Lau YK, Kwan A, Wong BC. Famotidine is inferior to pantoprazole in preventing recurrence of aspirin-related peptic ulcers or erosions. Gastroenterology. 2010 Jan;138(1):82-8. doi: 10.1053/j.gastro.2009.09.063. Epub 2009 Nov 11.
PubMed 19837071
Lanas A, Garcia-Rodriguez LA, Arroyo MT, Bujanda L, Gomollon F, Forne M, Aleman S, Nicolas D, Feu F, Gonzalez-Perez A, Borda A, Castro M, Poveda MJ, Arenas J; Investigators of the Asociacion Espanola de Gastroenterologia (AEG). Effect of antisecretory drugs and nitrates on the risk of ulcer bleeding associated with nonsteroidal anti-inflammatory drugs, antiplatelet agents, and anticoagulants. Am J Gastroenterol. 2007 Mar;102(3):507-15. doi: 10.1111/j.1572-0241.2006.01062.x.
PubMed 17338735
Ng FH, Wong SY, Chang CM, Chen WH, Kng C, Lanas AI, Wong BC. High incidence of clopidogrel-associated gastrointestinal bleeding in patients with previous peptic ulcer disease. Aliment Pharmacol Ther. 2003 Aug 15;18(4):443-9. doi: 10.1046/j.1365-2036.2003.01693.x.
PubMed 12940930
Laine L, Hennekens C. Proton pump inhibitor and clopidogrel interaction: fact or fiction? Am J Gastroenterol. 2010 Jan;105(1):34-41. doi: 10.1038/ajg.2009.638. Epub 2009 Nov 10.
PubMed 19904241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes

All Peptic Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users - a Double-blind Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02551744
Acronym / sponsor ID: VGHKS12-CT7-08
Conditions: Peptic Ulcer
Keywords: histamine-2 receptor antagonist, proton pump inhibitor, thienopyridine, clopidogrel, prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Kaohsiung Veterans General Hospital.University, hospital or other
Study start: Jul 2012
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 16 Sep 2015 (estimated)
Results: Posted 8 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
proton pump inhibitor group	Active comparator	Drug: proton pump inhibitor groupPantoprazole Tab 40mg qd for 6 monthrs.
histamine-2 receptor antagonist group	Experimental	Drug: histamine-2 receptor antagonist groupfamotidine Tab 40 mg qd for 6 months.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
histamine-2 receptor antagonist groupAlso: famotidine 40 mgfamotidine tab 40 mg qd for 6 months.	Drug	histamine-2 receptor antagonist group
proton pump inhibitor groupAlso: pantoprazole 40mgpantoprazole tab 40 mg qd for 6 months.	Drug	proton pump inhibitor group

Primary outcome

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

Results and safety

Results posted to the registry on 8 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Proton Pump Inhibitor Group	50	50
Histamine-2 Receptor Antagonist Group	51	51

Primary outcome: Number of Participants With Ulcer Recurrence

Time frame: six month. Number. Unit: participants

Measure	Proton Pump Inhibitor Group n = 50	Histamine-2 Receptor Antagonist Group n = 51
Value	1	7

Population analysed: Intention to treat

Adverse events

Time frame: six month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proton Pump Inhibitor Group	0 of 50 (0%)	1 of 50 (2%)	0 of 50
Histamine-2 Receptor Antagonist Group	0 of 51 (0%)	1 of 51 (2%)	0 of 51

Limitations and caveats (from the sponsor): The trial was performed in a single country

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16793712Savi P, Nurden P, Nurden AT, Levy-Toledano S, Herbert JM. Clopidogrel: a review of its mechanism of action. Platelets. 1998;9(3-4):251-5. doi: 10.1080/09537109876799.
Background: PubMed 15816504Boeynaems JM, van Giezen H, Savi P, Herbert JM. P2Y receptor antagonists in thrombosis. Curr Opin Investig Drugs. 2005 Mar;6(3):275-82.
Background: PubMed 11519503Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
Background: PubMed 16531616Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
Background: PubMed 11520521Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.
Background: PubMed 8918275CAPRIE 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.
Background: PubMed 10868447Fork FT, Lafolie P, Toth E, Lindgarde F. Gastroduodenal tolerance of 75 mg clopidogrel versus 325 mg aspirin in healthy volunteers. A gastroscopic study. Scand J Gastroenterol. 2000 May;35(5):464-9. doi: 10.1080/003655200750023705.
Background: PubMed 21144850Hsu 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.
Background: PubMed 15659723Chan FK, Ching JY, Hung LC, Wong VW, Leung VK, Kung NN, Hui AJ, Wu JC, Leung WK, Lee VW, Lee KK, Lee YT, Lau JY, To KF, Chan HL, Chung SC, Sung JJ. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005 Jan 20;352(3):238-44. doi: 10.1056/NEJMoa042087.
Background: PubMed 11353854Ma L, Elliott SN, Cirino G, Buret A, Ignarro LJ, Wallace JL. Platelets modulate gastric ulcer healing: role of endostatin and vascular endothelial growth factor release. Proc Natl Acad Sci U S A. 2001 May 22;98(11):6470-5. doi: 10.1073/pnas.111150798. Epub 2001 May 15.
Background: PubMed 15300570Laine L, Maller ES, Yu C, Quan H, Simon T. Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: a double-blind trial. Gastroenterology. 2004 Aug;127(2):395-402. doi: 10.1053/j.gastro.2004.05.001.
Background: PubMed 19837071Ng FH, Wong SY, Lam KF, Chu WM, Chan P, Ling YH, Kng C, Yuen WC, Lau YK, Kwan A, Wong BC. Famotidine is inferior to pantoprazole in preventing recurrence of aspirin-related peptic ulcers or erosions. Gastroenterology. 2010 Jan;138(1):82-8. doi: 10.1053/j.gastro.2009.09.063. Epub 2009 Nov 11.

Related trials for Peptic Ulcer

Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ping-I Hus, Bachelor study chair

Kaohsiung Veterans General Hospital.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing histamine-2 receptor antagonist group and proton pump inhibitor group in people with Peptic Ulcer, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Ulcer Recurrence (time frame: six month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02551744, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.