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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23560727 | Derived | 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. |
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Prior to undergoing 24 hour pH with impedance, all participants will receive either one week of esomeprazole or one week of placebo.
All eligible patients with suspected GERD will be referred to the manometry and reflux lab testing for potential recruitment into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | First Intervention (7 Days), Second Intervention (7 Days) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Received PPI Intervention |
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| Received Placebo Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed. | Posted | Mean | Standard Deviation | number of episodes | 1 week |
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One week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Arm | 0 | 45 | 0 | 45 | |||
| EG001 | PPI Arm | 0 | 44 | 0 | 44 |
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Single center study. Relatively small number of patients studied, although recruitment goal reached.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fouad J. Moawad | Walter Reed National Military Medical Center | (301) 400-1551 | Fouad.Moawad@us.army.mil |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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