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Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
This study is ongoing, but not recruiting participants.
First Received: March 10, 2008   Last Updated: 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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:


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
1: Active Comparator
Lansoprazole and dietary control
Drug: Lansoprazole
Lansoprazole 30 mg PO daily for 3 months
2: Placebo Comparator
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:

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

Keywords provided by University of Kansas:
dysphonia

Additional relevant MeSH terms:
Anti-Infective Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Hoarseness
Respiration Disorders
Nervous System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Signs and Symptoms
Respiratory Tract Diseases
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Neurologic Manifestations
Signs and Symptoms, Respiratory
Voice Disorders
Laryngeal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on February 08, 2010