Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

January 11, 2008 updated by: University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
All subjects will be given active drug.
Drug: Aciphex
20 mg of aciphex taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

  • Principal Investigator: Susan Thibeault, Ph.D., University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 11, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 11690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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