Laryngopharyngeal Reflux
Conditions
Keywords
laryngopharyngeal reflux, acid reflux, throat 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 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.
Interventions
DRUGdexlansoprazole
60 mg dexlansoprazole QAM (1 hour AC) for 2 months
DRUGPlacebo
1 tablet of placebo QAM (1 hour AC) for 2 months
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Reflux Symptom Index (RSI) | Baseline to 2 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexlansoprazole Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).
dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months | 9 |
| 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).
dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months | 2 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unrelated hospitalization | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Dexlansoprazole | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 9 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 2 |
| other Total, other adverse events | 0 / 9 | 0 / 2 |
| serious Total, serious adverse events | 0 / 9 | 0 / 2 |
Outcome results
Primary
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.
Time frame: Baseline to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole | Change in Reflux Symptom Index (RSI) | 18 units on a scale | Standard Deviation 3.95 |
| Sugar Pill | Change in Reflux Symptom Index (RSI) | 13 units on a scale | Standard Deviation 4.54 |