The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux

Study Overview
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Brief Summary
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Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (LPR) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.

Detailed Description
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The aim of the study is to compare outcomes, based on RSI-based symptomatic improvement and pharyngeal probe results, after LPR patients are treated for two months with once-daily (QAM) Kapidex versus placebo.Forty patients with pharyngeal pH probe-documented LPR and an elevated reflux symptom index (RSI) (≥14) will be enrolled into a double-blinded placebo controlled study. Twenty patients will receive Kapidex once daily, while twenty receive placebo. Patients will return at two months for evaluation with repeat RSI documentation and repeat pharyngeal pH probe testing. Student t-test will be used to determine if the change in RSI and pH-probe results differs between the study and placebo group.

Official Title
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A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux

Conditions
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Laryngopharyngeal Reflux

Intervention / Treatment
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* Drug: dexlansoprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:patients with an abnormal Restech pH probe study and also have an RSI of 14 or greater will be invited to participate in the study Exclusion Criteria:known intolerance or allergy to proton pump inhibitors, hypersecretory conditions (Zollinger-Ellison), self-reported anxiety/depression (shown to affect RSI),16 history of laryngeal irradiation, or have been on twice daily Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexlansoprazole<br>Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). | Drug: dexlansoprazole<br>* 60 mg dexlansoprazole QAM (1 hour AC) for 2 months<br>* Other names: Dexilant;|
| Placebo Comparator: Sugar pill<br>Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC). | Drug: Placebo<br>* 1 tablet of placebo QAM (1 hour AC) for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Reflux Symptom Index (RSI) | The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of >13 is considered to be abnormal. | Baseline to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngopharyngeal reflux, acid reflux, throat reflux