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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by University of Kansas. Recruitment status was Active, not recruiting

First Received on March 10, 2008. Last Updated on September 14, 2009 History of Changes

Sponsor:	University of Kansas
Collaborator:	TAP Pharmaceutical Products Inc.
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00637416

Purpose

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

Condition	Intervention
Pediatric Dysphonia	Drug: Lansoprazole Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Resource links provided by NLM:

Drug Information available for: Lansoprazole

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Quality of Life questionnaire, computer analysis of voice, trained listener analysis of voice [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Lansoprazole and dietary control	Drug: Lansoprazole Lansoprazole 30 mg PO daily for 3 months Other Name: Prevacid
Placebo Comparator: 2 Dietary control and placebo	Drug: placebo placebo PO daily for 3 months

Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy children with a diagnosis of dysphonia age 3-18 years.
Dysphonia must be present for at least one month duration.
May have vocal cord nodules present.
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.
Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
Caregiver must be able to read, write, and understand English.
Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.

Exclusion Criteria:

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.
Dysphonia must not be due to an acute upper respiratory infection.
Must not have been treated with PPI medication in the past 12 months.
Inability of child to cooperate with recording of voice for analysis.
Inability of caregiver to read, write, and understand English.
Mental retardation, cognitive impairment, or developmental delay.
History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637416

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

TAP Pharmaceutical Products Inc.

Investigators

Principal Investigator:

Julie Wei

University of Kansas

More Information

No publications provided

Responsible Party:	Julie Wei, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT00637416 History of Changes
Other Study ID Numbers:	10720
Study First Received:	March 10, 2008
Last Updated:	September 14, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

dysphonia

Additional relevant MeSH terms:

Hoarseness
Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Signs and Symptoms, Respiratory
Lansoprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012