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Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204698
First Posted: September 20, 2005
Last Update Posted: January 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah
  Purpose

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.


Condition Intervention Phase
Laryngopharyngeal Reflux Drug: Aciphex Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: August 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
All subjects will be given active drug.
Drug: Aciphex
20 mg of aciphex taken twice daily

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204698


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Principal Investigator: Susan Thibeault, Ph.D. University of Utah
  More Information

Publications:
Responsible Party: Susan Thibeault, Ph.D., University of Utah
ClinicalTrials.gov Identifier: NCT00204698     History of Changes
Other Study ID Numbers: IRB 11690
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: January 16, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Proton Pump Inhibitors
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents