Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

January 8, 2013 updated by: Fouad Moawad, Walter Reed National Military Medical Center
The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adults patients (age 18 or older) with reflux symptoms willing to participate

Exclusion Criteria:

  • Pregnancy
  • Prior esophageal or gastric surgery
  • Achalasia
  • Scleroderma
  • Gastroparesis.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm
Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
Drug: placebo
Active Comparator: Esomeprazole
Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
Drug: Esomeprazole
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Impedance Episodes Following PPI and Placebo
Time Frame: 1 week
Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.
1 week

Collaborators and Investigators

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

Sponsor

Walter Reed National Military Medical Center

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

September 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20593-8

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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Conditions

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Locations

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