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

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ClinicalTrials.gov Identifier: NCT01317472
Recruitment Status : Terminated (Principal investigator left institution)
First Posted : March 17, 2011
Last Update Posted : November 18, 2013
Information provided by (Responsible Party):
Indiana University

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.

Condition or disease Intervention/treatment
Laryngopharyngeal Reflux Drug: dexlansoprazole

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
Study Start Date : March 2011
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dexlansoprazole
Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).
Drug: dexlansoprazole
60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Other Name: Dexilant
Placebo Comparator: Sugar pill
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: dexlansoprazole
60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Other Name: Dexilant

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317472

United States, Indiana
Clarian North Hospital -- IUMG Clinic
Indianapolis, Indiana, United States, 46220
Sponsors and Collaborators
Indiana University
Principal Investigator: Stacey L Halum, MD Indiana University

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01317472     History of Changes
Other Study ID Numbers: MSA-NC-DEX-115
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: March 2012

Keywords provided by Indiana University:
laryngopharyngeal reflux, acid reflux, throat reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action