Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Information source: University of Kansas
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Dysphonia
Intervention: Lansoprazole (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Kansas Official(s) and/or principal investigator(s):
Julie Wei, Principal Investigator, Affiliation: University of Kansas
Overall contact:
Wei Julie, Phone: 913-588-6701, Email: jwei@kumc.edu
Summary
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary
control alone will improve pediatric hoarseness symptoms.
Clinical Details
Official title: The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Quality of Life questionnaire, computer analysis of voice, trained listener analysis of voice
Eligibility
Minimum age: 3 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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 PPI 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.
Locations and Contacts
Wei Julie, Phone: 913-588-6701, Email: jwei@kumc.edu
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Additional Information
Starting date: March 2008
Ending date: March 2010
Last updated: September 10, 2008
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