Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Pediatric Dysphonia Clinical Trial

Official title:

The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637416
• Other study ID #: 10720
• Status: Terminated
• Phase: N/A
• First received: March 10, 2008
• Last updated: April 22, 2013
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Pediatric Dysphonia

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	TAP Pharmaceutical Products Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life questionnaire, computer analysis of voice, trained listener analysis of voice		3 months	No