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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01710800
Other study ID # 20593-8
Secondary ID
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


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
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