Clinical Trial: The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Indiana University

Current Primary Outcome: Reflux Symptom Index (RSI) [ Time Frame: 2 months ]

Evaluating the change in the RSI will be a primary endpoint of the study and is anticipated to be significantly different between the study and control groups after two months of treatment with dexlansoprazole versus placebo, respectively.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: March 16, 2011
Date Started: March 2011
Date Completion:
Last Updated: November 14, 2013
Last Verified: March 2012