Not provided
Not provided
Not provided
Not provided
Not provided
Principal investigator left institution
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole | Experimental | Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). |
|
| Sugar pill | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexlansoprazole | Drug | 60 mg dexlansoprazole QAM (1 hour AC) for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2 months |
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stacey L Halum, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clarian North Hospital -- IUMG Clinic | Indianapolis | Indiana | 46220 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sugar Pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
very poor recruitment. patients were not willing to enter study because they did not want to take a chance on receiving placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terese Stevens, Dept administrator | Indiana University | 317-278-3187 | tstevens@iupui.edu |
Not provided
| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 1 tablet of placebo QAM (1 hour AC) for 2 months |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |