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OpenTrials
Completed

NCT Number: NCT00864396

Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevacid

Drug

30mg of Lansoprazole twice daily (or placebo)for eight weeks.

Primary outcomes

  1. To compare the efficacy of twice daily Lansoprazole 30mg to placebo in the treatment of laryngopharyngeal reflux symptoms and findings.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 18, 2009
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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