Dysphonia
Conditions
Keywords
horseness
Brief summary
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.
Interventions
DRUGLansoprazole
Lansoprazole 30 mg taken by mouth daily for 3 months
OTHERPlacebo
placebo taken by mouth daily for 3 months
Sponsors
TAP Pharmaceutical Products Inc.
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy children with a diagnosis of dysphonia age 3-18 years. 2. Dysphonia must be present for at least one month duration. 3. May have vocal cord nodules present. 4. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. 5. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel). 6. Caregiver must be able to read, write, and understand English. 7. Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.
Exclusion criteria
1. Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy. 2. Dysphonia must not be due to an acute upper respiratory infection. 3. Must not have been treated with proton pump inhibitor medication in the past 12 months. 4. Inability of child to cooperate with recording of voice for analysis. 5. Inability of caregiver to read, write, and understand English. 6. Mental retardation, cognitive impairment, or developmental delay. 7. History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Condition Over Treatment Period | 3 months | Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lansoprazole and Dietary Control Lansoprazole and dietary control
Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months | 4 |
| Placebo and Dietary Control Dietary control and placebo
Placebo: placebo taken by mouth daily for 3 months | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Unable to take study drug | 0 | 1 |
Baseline characteristics
| Characteristic | Lansoprazole and Dietary Control | Placebo and Dietary Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 2 Participants | 2 Participants | 4 Participants |
| Gender Male | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
Change in Condition Over Treatment Period
Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).
Time frame: 3 months
Population: Study was stopped early, data were not collected, and zero participants were analyzed.