NCT01317472

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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

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.

Conditions

• Laryngopharyngeal Reflux

Interventions

Type	Name	Description
DRUG	dexlansoprazole	60 mg dexlansoprazole QAM (1 hour AC) for 2 months
DRUG	Placebo	1 tablet of placebo QAM (1 hour AC) for 2 months

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-03-17
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

1 site across 1 country: United States