Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed

June 29, 2017 updated by: University of Missouri-Columbia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are few clinical practice guidelines for the management of a non-variceal, upper gastrointestinal bleed (UGIB). The 2012 guidelines released by the American College of Gastroenterology (ACG) indicate that for active bleeding or non-bleeding visible vessels or adherent clot, a bolus of 80 mg proton pump inhibitor followed by continuous infusion of 8 mg/hr infusion is to be used. Following 72 hours of infusion therapy, an oral proton pump inhibitor (PPI) may be used. If the clot is a flat pigmented spot or a clean ulcer base, an oral proton pump inhibitor may be used for management (without infusion) (Laine 2012). There are no recommendations made on once versus twice daily proton pump inhibitor. The 2010 American College of Physicians guideline recommends following the 72-hour infusion with once-daily proton pump inhibitors for duration as dictated by underlying etiology following upper gastrointestinal bleeding (UGIB) (Barkun 2012). This recommendation is graded 1C, with the decision to support once-daily over twice-daily dosing due to demonstrated effective ulcer healing for patients with peptic ulcer disease with once-daily dosing, and insufficient data to suggest twice-daily is superior to once-daily. There have been no head-to-head trials to evaluate once-daily versus twice-daily proton pump inhibitor following acute management of an endoscopic bleed. Additionally, studies suggest about 50% to 60% of proton pump inhibitors are being used without appropriate indications or at inappropriate dosages (Ali 2009).Safety concerns such as increased risk for Clostridium difficile infection , community acquired pneumonia, electrolyte abnormalities (hypomagnesemia), and fractures are becoming more prevalent warranting improved risk versus benefit examination of proton pump inhibitors including ascertainment of least effective dosing (Ali 2009, Sheen 2011). Despite recommendations to discharge patients after acute management of UGIB on once daily PPI therapy, clinical practice is to use twice daily proton pump inhibitor therapy. The objective of this study will be to examine if once daily pantoprazole is non-inferior to twice daily pantoprazole with regards to ulcer healing after acute management of an UGIB. In addition, because more evidence is emerging regarding safety concerns with proton pump inhibitors, the study will seek to examine if once daily versus twice daily therapy results in difference in safety or adverse reactions such as occurrence of rebleed, C. difficile diarrhea, or pneumonia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65112
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pantoprazole twice daily
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Drug: Pantoprazole
Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
Other Names:
  • Protonix
Active Comparator: Pantoprazole once daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Drug: Pantoprazole
Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
Other Names:
  • Protonix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ulcer Healing
Time Frame: 8 weeks
as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Rebleed
Time Frame: 8 weeks

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

High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management
8 weeks
Clostridium Difficile Diarrhea
Time Frame: 8 weeks
Clostridium difficile confirmed by polymerase chain reaction (PCR)
8 weeks
Community-Acquired Pneumonia
Time Frame: 8 weeks
As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashley M Ausmus, Pharm.D., University of Missouri-Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1212917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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