Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00204698
First received: September 13, 2005
Last updated: January 11, 2008
Last verified: January 2008

September 13, 2005
January 11, 2008
August 2003
May 2006   (final data collection date for primary outcome measure)
The presence of proinflammatory cytokines will be measured at the gene and protein expression levels from PL biopsies with gene specific semiquantitative reverse transcription-polymerase chain reaction and western blot analysis. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The presence of proinflammatory cytokines will be measured at the gene and protein expression levels from PL biopsies with gene specific semiquantitative reverse transcription-polymerase chain reaction and western blot analysis.
Complete list of historical versions of study NCT00204698 on ClinicalTrials.gov Archive Site
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Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment
Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment

This study proposes to investigate prospectively, the presence of molecular markers for inflammation in laryngopharyngeal reflux (LPR) patients and to study the effect of a proton pump inhibitor (Aciphex) on these molecular markers.

The investigators will be evaluating a group of patients before and after treatment. This group will be patients that have untreated laryngopharyngeal reflux diagnosed by laryngoscopic assessment and a 24-hour probe.

Objectives:

This study proposes to investigate prospectively, the presence of molecular markers for inflammation in LPR patients and to study the effect of a proton pump inhibitor on these molecular markers. This study will provide important data regarding the etiology of LPR. It will also provide vital information about the present standard treatment for LPR and why it is not universally successful.

Patient Selection Criteria:

The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.

Design:

The presence of proinflammatory cytokines will be measured at the gene and protein expression levels from PL biopsies with gene specific semiquantitative reverse transcription-polymerase chain reaction and Western Blot analysis.

Statistical Methods, Data Analysis, and Interpretation:

Null Hypothesis: There will be no difference in cytokine expression in the posterior larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with Aciphex, a proton pump inhibitor.

Alternative Hypothesis: There will be a difference in cytokine expression in the posterior larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with Aciphex, a proton pump inhibitor.

Effect size = 30% (based upon review of the literature for cytokines in inflammatory states)

Standard Deviation = 30

Standard Effect Size = effect size/standard deviation = 30/30 = 1

With an alpha of 0.05, power 0.1 (90% power), sample size should be 22. Therefore we have chosen 25 subjects in case of error in molecular studies.

Paired t-tests will be utilized to compare differences between cytokine levels for experimental group initiation and completion of medication.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Laryngopharyngeal Reflux
Drug: Aciphex
20 mg of aciphex taken twice daily
Active Comparator: 1
All subjects will be given active drug.
Intervention: Drug: Aciphex
Thibeault SL, Smith ME, Peterson K, Ylitalo-Moller R. Gene expression changes of inflammatory mediators in posterior laryngitis due to laryngopharyngeal reflux and evolution with PPI treatment: a preliminary study. Laryngoscope. 2007 Nov;117(11):2050-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204698
IRB 11690
No
Susan Thibeault, Ph.D., University of Utah
University of Utah
PriCara, Unit of Ortho-McNeil, Inc.
Principal Investigator: Susan Thibeault, Ph.D. University of Utah
University of Utah
January 2008

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