Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

Phase 1

Completed

• Conditions: Laryngopharyngeal Reflux
• Interventions: Drug: Prevacid

• Registration Number: NCT00864396
• Lead Sponsor: University of California, Davis

Brief Summary

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

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).

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-03
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevacid	Prevacid	-

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of twice daily Lansoprazole 30mg to placebo in the treatment of laryngopharyngeal reflux symptoms and findings.	8 weeks

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States