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Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

Primary Purpose

Laryngopharyngeal Reflux

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aciphex
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

All subjects will be given active drug.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
January 11, 2008
Sponsor
University of Utah
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00204698
Brief Title
Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment
Official Title
Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
All subjects will be given active drug.
Intervention Type
Drug
Intervention Name(s)
Aciphex
Intervention Description
20 mg of aciphex taken twice daily
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Thibeault, Ph.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17721405
Citation
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. doi: 10.1097/MLG.0b013e318124a992.
Results Reference
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Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

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