Official Title: “The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness”

This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Lansoprazole
  • Lansoprazole 30 mg PO daily for 3 months
• Drug: placebo
  • placebo PO daily for 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Lansoprazole and dietary control
• Placebo Comparator: 2
  • Dietary control and placebo

Primary Measures

• Quality of Life questionnaire, computer analysis of voice, trained listener analysis of voice
  • Time Frame: 3 months
    Safety Issue?: 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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Kansas

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637416

Study ID Number: 10720

ClinicalTrials.gov Identifier: NCT00637416

Health Authority: United States: Institutional Review Board