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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710800
• Other study ID #: 20593-8
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: January 8, 2013
• Start date: September 2008
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• Esomeprazole

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Impedance Episodes Following PPI and Placebo	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	No