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

This study has been terminated.
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Julie Wei, MD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00637416
First received: March 10, 2008
Last updated: April 22, 2013
Last verified: September 2012

March 10, 2008
April 22, 2013
March 2008
July 2009   (final data collection date for primary outcome measure)
Quality of Life questionnaire, computer analysis of voice, trained listener analysis of voice [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00637416 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pediatric Dysphonia
  • Drug: Lansoprazole
    Lansoprazole 30 mg PO daily for 3 months
    Other Name: Prevacid
  • Drug: placebo
    placebo PO daily for 3 months
  • Active Comparator: 1
    Lansoprazole and dietary control
    Intervention: Drug: Lansoprazole
  • Placebo Comparator: 2
    Dietary control and placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
3 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00637416
10720
No
Julie Wei, MD, University of Kansas
University of Kansas
TAP Pharmaceutical Products Inc.
Principal Investigator: Julie Wei University of Kansas
University of Kansas
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP