Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment
Overview[ - collapse ][ - ]
| 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 | Laryngopharyngeal Reflux |
| Intervention | Drug: Aciphex |
| Phase | Phase 2/Phase 3 |
| Sponsor | University of Utah |
| Responsible Party | University of Utah |
| ClinicalTrials.gov Identifier | NCT00204698 |
| First Received | September 13, 2005 |
| Last Updated | January 11, 2008 |
| Last verified | January 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2005 |
|---|---|
| Last Updated Date | January 11, 2008 |
| Start Date | August 2003 |
| Estimated Primary Completion Date | May 2006 |
| Current 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] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Laryngopharyngeal Reflux |
| Intervention | Drug: Aciphex 20 mg of aciphex taken twice daily |
| Study Arm (s) | Active Comparator: 1 All subjects will be given active drug. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 24 |
| Estimated Completion Date | May 2006 |
| Estimated Primary Completion Date | May 2006 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00204698 |
|---|---|
| Other Study ID Numbers | IRB 11690 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Utah |
| Study Sponsor | University of Utah |
| Collaborators | PriCara, Unit of Ortho-McNeil, Inc. |
| Investigators | Principal Investigator: Susan Thibeault, Ph.D. University of Utah |
| Verification Date | January 2008 |
Locations[ + expand ][ + ]
| University of Utah | Salt Lake City, Utah, United States, 84132 |
|---|