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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Dysphonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lansoprazole and dietary control

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

Lansoprazole 30 mg taken by mouth daily for 3 months

Placebo and dietary control

Dietary control and placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo taken by mouth daily for 3 months

Interventions

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Lansoprazole

Lansoprazole 30 mg taken by mouth daily for 3 months

Intervention Type DRUG

Placebo

placebo taken by mouth daily for 3 months

Intervention Type OTHER

Other Intervention Names

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Prevacid

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No