Trial Outcomes & Findings for Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease (NCT NCT00388453)
NCT ID: NCT00388453
Last Updated: 2017-06-27
Results Overview
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
COMPLETED
NA
47 participants
24 hours
2017-06-27
Participant Flow
Volunteers for all three groups were recruited from the Vanderbilt Medical Center
Participant milestones
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With History of Gastroesophageal Reflux Disease
Patients with a history of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of their symptoms with PPI use and if they had erosive esophagitis by Los Angeles classification at endoscopy.
|
Volunteers With Laryngopharangeal Reflux (LPR)
Patients suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing and hoarseness. This group included non-smokers with unremarkable chest radiographs who had undergone extensive testing and exclusion of other common causes for their laryngeal symptoms by the Vanderbilt Allergy, Sinus and Asthma Program (ASAP), and Vanderbilt Voice Center (spirometry, methacholine challenge, sputum eosinophil count, otolaryngology exam, high-resolution computerized tomography scan of the thorax and sinuses and sinus testing).
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
10
|
|
Overall Study
COMPLETED
|
20
|
17
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
n=20 Participants
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With Gastroesophageal Reflux Disaese (GERD)
n=17 Participants
History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy
|
Volunteers With Laryngopharangeal Reflux (LPR)
n=10 Participants
Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
17 participants
n=4 Participants
|
10 participants
n=27 Participants
|
47 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
Outcome measures
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
n=20 Participants
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With History of Gastroesophageal Reflux Disease
n=17 Participants
GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
|
Volunteers With Laryngopharangeal Reflux (LPR)
n=10 Participants
Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
|
|---|---|---|---|
|
Decrease in pH From Baseline to <4
|
1.1 distal esophagus total % time pH <4
Interval 0.5 to 3.9
|
3.2 distal esophagus total % time pH <4
Interval 1.5 to 8.7
|
3.8 distal esophagus total % time pH <4
Interval 1.8 to 6.7
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
Outcome measures
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
n=20 Participants
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With History of Gastroesophageal Reflux Disease
n=17 Participants
GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
|
Volunteers With Laryngopharangeal Reflux (LPR)
n=10 Participants
Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
|
|---|---|---|---|
|
Decrease in pH From Baseline to <5
|
3.0 distal esophagus total % time pH <5
Interval 1.9 to 8.3
|
6.5 distal esophagus total % time pH <5
Interval 4.4 to 27.0
|
13 distal esophagus total % time pH <5
Interval 3.6 to 19.0
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
Outcome measures
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
n=20 Participants
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With History of Gastroesophageal Reflux Disease
n=17 Participants
GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
|
Volunteers With Laryngopharangeal Reflux (LPR)
n=10 Participants
Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
|
|---|---|---|---|
|
Decrease in pH From Baseline to <6
|
11 distal esophagus total % time pH <6
Interval 8.6 to 27.0
|
29 distal esophagus total % time pH <6
Interval 12.0 to 54.0
|
31 distal esophagus total % time pH <6
Interval 19.0 to 58.0
|
SECONDARY outcome
Timeframe: 24 hoursReflux event was calculated for a drop in pH from baseline to \<6 and each event had to last more than 5 seconds and could not be during the meals.
Outcome measures
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
n=20 Participants
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With History of Gastroesophageal Reflux Disease
n=17 Participants
GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
|
Volunteers With Laryngopharangeal Reflux (LPR)
n=10 Participants
Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
|
|---|---|---|---|
|
Number of Reflux Events
|
6.5 reflux events
Interval 0.0 to 35.0
|
102 reflux events
Interval 5.0 to 181.0
|
75 reflux events
Interval 45.0 to 177.0
|
Adverse Events
Healthy Volunteers With no History of GERD or EERD or PPI Use
Volunteers With Gastroesphageal Reflux Disease (GERD)
Volunteers With Laryngopharangeal Reflux (LPR)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers With no History of GERD or EERD or PPI Use
n=20 participants at risk
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
|
Volunteers With Gastroesphageal Reflux Disease (GERD)
n=17 participants at risk
GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at time of endoscopy.
|
Volunteers With Laryngopharangeal Reflux (LPR)
n=10 participants at risk
Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
|
|---|---|---|---|
|
Gastrointestinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/10 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place