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

NCT01710800 | Completed Results DMC

• 1 other identifier: 20593-8
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GERD

Keywords

impedance; reflux; GERD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

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

Drug: placebo

Esomeprazole

ACTIVE COMPARATOR

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

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

Also known as: Nexium

Esomeprazole

placebo DRUG

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults patients (age 18 or older) with reflux symptoms willing to participate

You may not qualify if:

• Pregnancy
• Prior esophageal or gastric surgery
• Achalasia
• Scleroderma
• Gastroparesis.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Related Publications (1)

• Moawad FJ, Betteridge JD, Boger JA, Cheng FK, Belle LS, Chen YJ, Maydonovitch CL, Wong RK. Reflux episodes detected by impedance in patients on and off esomeprazole: a randomised double-blinded placebo-controlled crossover study. Aliment Pharmacol Ther. 2013 May;37(10):1011-8. doi: 10.1111/apt.12301. Epub 2013 Apr 7.

  PMID: 23560727 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Single center study. Relatively small number of patients studied, although recruitment goal reached.

Results Point of Contact

• Title: Dr. Fouad J. Moawad
• Organization: Walter Reed National Military Medical Center

Fouad.Moawad@us.army.mil

(301) 400-1551

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 9, 2013
• Results First Posted: January 9, 2013

Record last verified: 2012-11