The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
Information source: Indiana University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laryngopharyngeal Reflux
Intervention: dexlansoprazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s):
Stacey L Halum, MD, Principal Investigator, Affiliation: Indiana University
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.
Clinical Details
Official title: A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Reflux Symptom Index (RSI)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Clarian North Hospital -- IUMG Clinic, Indianapolis, Indiana 46220, United States; Recruiting
Stacey L Halum, MD, Phone: 317-688-4824, Email: shalum@iupui.edu
Heather Hillman, RN, Phone: 317-688-4864, Email: hhillman@iuhealth.org
Stacey L Halum, MD, Principal Investigator
Additional Information
Starting date: March 2011
Last updated: March 29, 2012
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