Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed

NCT02235311 | Terminated Results DMC

• 1 other identifier: 1212917
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Despite recommendations from clinical practice guidelines to discharge patients from the hospital on once daily proton pump inhibitors after acute management of UGIB, clinical practice is to use twice daily proton pump inhibitor therapy. The objective of this study will be to assess whether or not once daily pantoprazole is non-inferior to twice daily pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe for any potential difference in safety for once daily versus twice daily proton pump inhibitors.

Conditions

Upper Gastrointestinal Bleed

Keywords

Proton pump inhibitor; Upper gastrointestinal bleed; Ulcer healing

Outcome Measures

Primary Outcomes (1)

• Ulcer Healing

  as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management

  8 weeks

Secondary Outcomes (3)

• Rate of Rebleed

  8 weeks

• Clostridium Difficile Diarrhea

  8 weeks

• Community-Acquired Pneumonia

  8 weeks

Study Arms (2)

Pantoprazole twice daily

ACTIVE COMPARATOR

Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB

Drug: Pantoprazole

Pantoprazole once daily

ACTIVE COMPARATOR

Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB

Also known as: Protonix

Pantoprazole once daily; Pantoprazole twice daily

Eligibility Criteria

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

You may qualify if:

• Adult, 18 years and older; Upper GI bleed confirmed by endoscopy

You may not qualify if:

• Intensive Care Unit admission, Emergency endoscopic intervention required to control bleeding, Malignant appearing ulcers as determined by endoscopy, Previous documented treatment with twice daily PPI for other indication, Receiving twice daily PPI therapy prior to admission

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65112, United States

Location

Related Publications (6)

• Ali T, Roberts DN, Tierney WM. Long-term safety concerns with proton pump inhibitors. Am J Med. 2009 Oct;122(10):896-903. doi: 10.1016/j.amjmed.2009.04.014.

  PMID: 19786155 BACKGROUND

• Masso Gonzalez EL, Garcia Rodriguez LA. Proton pump inhibitors reduce the long-term risk of recurrent upper gastrointestinal bleeding: an observational study. Aliment Pharmacol Ther. 2008 Sep 1;28(5):629-37. doi: 10.1111/j.1365-2036.2008.03780.x. Epub 2008 Jun 26.

  PMID: 18616644 BACKGROUND

• Holster IL, Kuipers EJ. Management of acute nonvariceal upper gastrointestinal bleeding: current policies and future perspectives. World J Gastroenterol. 2012 Mar 21;18(11):1202-7. doi: 10.3748/wjg.v18.i11.1202.

  PMID: 22468083 BACKGROUND

• Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.

  PMID: 22310222 BACKGROUND

• Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.

  PMID: 20083829 BACKGROUND

• Sheen E, Triadafilopoulos G. Adverse effects of long-term proton pump inhibitor therapy. Dig Dis Sci. 2011 Apr;56(4):931-50. doi: 10.1007/s10620-010-1560-3. Epub 2011 Mar 2.

  PMID: 21365243 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

trial eliminated due to very low enrollment Poorly adopted by GI department due to fears of using once daily PPI despite available evidence Need for expansion to more sites for better enrollment

Results Point of Contact

• Title: Ashley McCormick, PharmD, BCPS
• Organization: University of Missouri - Columbia

ausmusash@health.missouri.edu

573-771-7798

Study Officials

• Ashley M Ausmus, Pharm.D.

  University of Missouri-Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: October 1, 2014
• Primary Completion: August 17, 2015
• Study Completion: August 17, 2015
• Last Updated: July 31, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)