Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment with twice-daily Lansoprazole 30mg (Prevacid 30mg) and behavioral modifications for reflux is superior to treatment with behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (LPR).

Detailed Description
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Laryngopharyngeal reflux (LPR) is a disorder caused by acid-induced damage to the larynx and pharynx (voice box and throat). The standard care for persons with this disorder is treatment with highly potent anti-acid medications (proton pump inhibitors - Prevacid is one of these. NExium, Aciphex and Prilosec are others). These medications are currently approved by the FDA for the treatment of gastroesophageal reflux disease (GERD). Although the use of these medications in persons with LPR is widely accepted and sanctioned, this research is being done because these medications are not currently approved by the FDA for this use. The purpose of this study is to determine whether treatment with twice-daily Lansoprazole 30mg (Prevacid 30mg) and behavioral modifications for reflux is superior to treatment with behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (LPR).

Official Title
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Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux: A Double-Blind, Placebo Controlled, Randomized Clinical Trial

Conditions
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Laryngopharyngeal Reflux

Intervention / Treatment
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* Drug: Prevacid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a clinical diagnosis of laryngopharyngeal reflux diagnosed by any combination of patient symptoms, physical/endoscopic findings, and 24 hr dual-probe ambulatory pH-testing. 18 years of age or older Exclusion Criteria: patients with life-threatening complications of laryngeal, pharyngeal or esophageal cancer, subglottic or tracheal stenosis, laryngeal papilloma, airway compromise elite vocal performs with LPR-related dysphonia under 18 years of age pregnant and/or lactating women persons with known hypersensitivity to any component of the formulation patients taking theophylline, ketoconazole, ampicillin or digoxin persons with hepatic and renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevacid<br> | Drug: Prevacid<br>* 30mg of Lansoprazole twice daily (or placebo)for eight weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of twice daily Lansoprazole 30mg to placebo in the treatment of laryngopharyngeal reflux symptoms and findings. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngopharyngeal reflux, Gastroesophageal reflux disease, GERD