Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

University of California (UC) Davis

Status and phase: Completed; Phase 1

Conditions: Laryngopharyngeal Reflux

Treatments: Drug: Prevacid

Study type: Interventional

Funder types: Other

Identifiers

NCT00864396

200513298

Details and patient eligibility

About

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).

Full 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).

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Prevacid

Experimental group

Treatment:

Drug: Prevacid