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Enrollment challenges
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| Name | Class |
|---|---|
| TAP Pharmaceutical Products Inc. | INDUSTRY |
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This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole and dietary control | Active Comparator | Lansoprazole and dietary control |
|
| Placebo and dietary control | Placebo Comparator | Dietary control and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | Lansoprazole 30 mg taken by mouth daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Condition Over Treatment Period | Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Wei | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole and Dietary Control | Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months |
| FG001 | Placebo and Dietary Control | Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole and Dietary Control | Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months |
| BG001 | Placebo and Dietary Control | Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months |
| 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 Condition Over Treatment Period | Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS). | Study was stopped early, data were not collected, and zero participants were analyzed. | Posted | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lansoprazole and Dietary Control | Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, ENT Clinical Research | University of Kansas Medical Center | (913) 588-7154 | ksykes@kumc.edu |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Other | placebo taken by mouth daily for 3 months |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo and Dietary Control | Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months | 0 | 5 | 0 | 5 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |