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

March 17, 2009
March 17, 2009
July 2005
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux
Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux: A Double-Blind, Placebo Controlled, Randomized Clinical Trial

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).

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).

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Laryngopharyngeal Reflux
Drug: Prevacid
30mg of Lansoprazole twice daily (or placebo)for eight weeks.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864396
200513298-2
Yes
Peter Belafsky, MD, Ph.D., University of California Davis
University of California, Davis
Not Provided
Principal Investigator: Peter Belafsky, MD, Ph.D. University of California, Davis
University of California, Davis
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP