The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
| Status: | Terminated |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | March 2011 |
| End Date: | November 2013 |
A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
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 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.
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 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.
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.
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.
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 PPI therapy for greater than
2 months without symptomatic relief (with an RSI ≥14)
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