Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Dysphonia
In brief
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.
Key facts
- Study ID
- NCT00637416
- Run by
- University of Kansas Medical Center
- People needed
- 9
- Starts
- 2008-03-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2017-01-23
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Healthy children with a diagnosis of dysphonia age 3-18 years.
- Dysphonia must be present for at least one month duration.
- May have vocal cord nodules present.
- 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.
- Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
- Caregiver must be able to read, write, and understand English.
- Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.
You may not qualify if…
- 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.
- Dysphonia must not be due to an acute upper respiratory infection.
- Must not have been treated with proton pump inhibitor medication in the past 12 months.
- Inability of child to cooperate with recording of voice for analysis.
- Inability of caregiver to read, write, and understand English.
- Mental retardation, cognitive impairment, or developmental delay.
- History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.
Where it is running
- University of Kansas Medical Center — Kansas City, Kansas, United States
Full record on ClinicalTrials.gov
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