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

Walter Reed National Military Medical Center

Status: Completed

Conditions: GERD

Treatments: Drug: placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01710800

20593-8

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Esomeprazole

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole