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

• Sponsor: Walter Reed National Military Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01710800
• Collaborator: (none)
• Enrollment: 41
• Arms: 2
• Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: Esomeprazole; Drug: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo arm 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
Active Comparator: Esomeprazole 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; Other Names: Nexium

Outcome Measures

Primary Outcome Measures

1. Number of Impedance Episodes Following PPI and Placebo [1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Walter Reed National Military Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fouad Moawad, Gastroenterologist, Walter Reed National Military Medical Center
• ClinicalTrials.gov Identifier: NCT01710800
• Other Study ID Numbers: 20593-8
• First Posted: Oct 19, 2012
• Last Update Posted: Jan 9, 2013
• Last Verified: Nov 1, 2012

• Keywords provided by Fouad Moawad, Gastroenterologist, Walter Reed National Military Medical Center: impedance; reflux; GERD
• Additional relevant MeSH terms: Esomeprazole

Study Results

Participant Flow

Recruitment Details	All eligible patients with suspected GERD will be referred to the manometry and reflux lab testing for potential recruitment into the study
Pre-assignment Detail	Prior to undergoing 24 hour pH with impedance, all participants will receive either one week of esomeprazole or one week of placebo.

Arm/Group Title	First Intervention (7 Days), Second Intervention (7 Days)
Arm/Group Description	Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
Period Title: Overall Study
STARTED	63
Received PPI Intervention	44
Received Placebo Intervention	45
COMPLETED	41
NOT COMPLETED	22

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
Overall Participants	41
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	41 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (12)
Sex: Female, Male (Count of Participants)
Female	24 58.5%
Male	17 41.5%
Region of Enrollment (participants) [Number]
United States	41 100%

Outcome Measures

1. Primary Outcome

Title	Number of Impedance Episodes Following PPI and Placebo
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.

Arm/Group Title	Placebo Arm	Esomeprazole
Arm/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	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
Measure Participants	41	41
Mean (Standard Deviation) [number of episodes]	47 (22)	53 (29)

Adverse Events

Time Frame	One week
Arm/Group Title	Placebo Arm		PPI Arm
Arm/Group Description
All Cause Mortality
	Placebo Arm		PPI Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Arm		PPI Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Arm		PPI Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/44 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.