N/A
Completed N=47
Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease
GERD · Larynx Disease
Source: ClinicalTrials.gov NCT00388453 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Decrease in pH From Baseline to <4 — 1.1; 3.2; 3.8 distal esophagus total % time pH <4 — p=.05
Summary
The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in pH From Baseline to <4 |
1.1; 3.2; 3.8 | .05 |
| PRIMARY Decrease in pH From Baseline to <5 |
3.0; 6.5; 13 | — |
| PRIMARY Decrease in pH From Baseline to <6 |
11; 29; 31 | — |
| SECONDARY Number of Reflux Events |
6.5; 102; 75 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female volunteers aged 18 to 65 years old.
- Control group: No known history of GERD or EERD or prior PPI use.
- GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
- EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.
Exclusion Criteria
- Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
- Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
- Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
- Expected non-compliance.
- Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
- Recent nasal surgery or nasal obstruction.
- Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00388453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.