N/A N=63 Randomized Double-blind Diagnostic

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

GERD

Bottom Line

View on ClinicalTrials.gov: NCT01710800 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcome: Primary: Number of Impedance Episodes Following PPI and Placebo — 47; 53 number of episodes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Esomeprazole (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Walter Reed National Military Medical Center
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Impedance Episodes Following PPI and Placebo	47; 53	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01710800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.