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

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.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

Other names: Nexium

Placebo

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Oct 19, 2012
Registry last updated: Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed