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Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00864396
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Laryngopharyngeal Reflux
 Drug: Prevacid
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux: A Double-Blind, Placebo Controlled, Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • To compare the efficacy of twice daily Lansoprazole 30mg to placebo in the treatment of laryngopharyngeal reflux symptoms and findings. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: July 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Prevacid
    30mg of Lansoprazole twice daily (or placebo)for eight weeks.
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864396

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Peter Belafsky, MD, Ph.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Peter Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00864396     History of Changes
Other Study ID Numbers: 200513298-2
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Laryngopharyngeal reflux
Gastroesophageal reflux disease
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013