Status:
TERMINATED
Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
TAP Pharmaceutical Products Inc.
Conditions:
Dysphonia
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
Brief Summary
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00637416
Start Date
March 1 2008
End Date
July 1 2009
Last Update
January 23 2017
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160