Phase 4
N=38
Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?
Larynx Disease · Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00444145 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prevacid (Drug); Esophageal and Laryngeal Biopsies (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy |
— | — |
Summary
The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy.
The hypothesis is that the patients who have laryngeal signs and symptoms related to acid reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of response to therapy.
Eligibility Criteria
Inclusion Criteria
GERD
- Documented erosive esophagitis:
- Patients will be newly diagnosed with esophageal erosion at initial visit via EGD
- Patients with non-erosive esophagitis who have been responsive to PPI
LPR
- Diagnosed via Head & Neck Institute endoscopists:
- pts with chronic (> 3-months) history of hoarseness, throat clearing, sore- or burning throat and globus
- Documentation of LPR using Larynx/Pharynx exam.
This group is commonly evaluated at the Vanderbilt Voice Center.
Exclusion Criteria
- Age 2 /day) alcohol use.
- Use of antacid (PPI, H2RB) within last 30 days
- Use of any/all medications affecting gastrointestinal motility
- Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric resection
- Patients unable to give informed consent
- Patients unable to comply with follow-up
- Patients with known contraindication to lansoprazole.
- Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergic to the local anesthetics.
Data sourced from ClinicalTrials.gov (NCT00444145). 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.