Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204698
Status:
COMPLETED
Last Update Posted:
2008-01-16
First Post:
2005-09-13
Brief Title:
Laryngopharyngeal Reflux and Proton Pump Inhibitor PPI Treatment
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 sizestandard deviation 3030 1
With an alpha of 005 power 01 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
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 sizestandard deviation 3030 1
With an alpha of 005 power 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None