Phase 4 Completed N=38 Treatment

Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

Larynx Disease · Gastroesophageal Reflux Disease

Source: ClinicalTrials.gov NCT00444145 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy — 0 participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Dilation of Intracellular Spaces 3 Months After 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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.