GERD
Conditions
Keywords
impedance, reflux, GERD
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.
Interventions
DRUGEsomeprazole
DRUGplacebo
Sponsors
Walter Reed National Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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 details
Prior to undergoing 24 hour pH with impedance, all participants will receive either one week of esomeprazole or one week of placebo.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 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. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 |
Outcome results
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.
Time frame: 1 week
Population: We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Arm | Number of Impedance Episodes Following PPI and Placebo | 47 number of episodes | Standard Deviation 22 |
| Esomeprazole | Number of Impedance Episodes Following PPI and Placebo | 53 number of episodes | Standard Deviation 29 |