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

Phase 4

Terminated

• Conditions: Dysphonia
• Interventions: Other: Placebo; Drug: Lansoprazole

• Registration Number: NCT00637416
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-18
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2016-10-05
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Results First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 proton pump inhibitor 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and dietary control	Placebo	Dietary control and placebo
Lansoprazole and dietary control	Lansoprazole	Lansoprazole and dietary control

Primary Outcome Measures

Name	Time	Method
Change in Condition Over Treatment Period	3 months	Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States