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

Primary Purpose

Laryngopharyngeal Reflux

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dexlansoprazole
Placebo
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux focused on measuring laryngopharyngeal reflux, acid reflux, throat reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)

Sites / Locations

  • Clarian North Hospital -- IUMG Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexlansoprazole

Sugar pill

Arm Description

Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).

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).

Outcomes

Primary Outcome Measures

Change in Reflux Symptom Index (RSI)
The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of >13 is considered to be abnormal.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2011
Last Updated
September 6, 2019
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01317472
Brief Title
The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
Official Title
A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator left institution
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux
Keywords
laryngopharyngeal reflux, acid reflux, throat reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexlansoprazole
Arm Type
Experimental
Arm Description
Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet of placebo QAM (1 hour AC) for 2 months
Primary Outcome Measure Information:
Title
Change in Reflux Symptom Index (RSI)
Description
The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of >13 is considered to be abnormal.
Time Frame
Baseline to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey L Halum, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clarian North Hospital -- IUMG Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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