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

Not Applicable

Completed

• Conditions: GERD
• Interventions: Drug: placebo; Drug: Esomeprazole

• Registration Number: NCT01710800
• Lead Sponsor: Walter Reed National Military Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-19
• Results First Submitted: 2012-10-24
• Status Verified: 2012-11
• Results First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Results First Posted: 2013-01-09
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo arm	placebo	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
Esomeprazole	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

Primary Outcome Measures

Name	Time	Method
Number of Impedance Episodes Following PPI and Placebo	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.