Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

Laryngopharyngeal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864396
• Other study ID #: 200513298
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2009
• Last updated: March 22, 2017
• Start date: July 2005
• Est. completion date: May 2008

Study information

• Verified date: March 2009
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Intervention

Drug:
• Prevacid
30mg of Lansoprazole twice daily (or placebo)for eight weeks.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of twice daily Lansoprazole 30mg to placebo in the treatment of laryngopharyngeal reflux symptoms and findings.		8 weeks