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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.
(Enrollment challenges)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637416
First Posted: March 18, 2008
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center
March 10, 2008
March 18, 2008
October 5, 2016
January 23, 2017
January 23, 2017
March 2008
July 2009   (Final data collection date for primary outcome measure)
Change in Condition Over Treatment Period [ Time Frame: 3 months ]
Change measured using voice assessment protocol—Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).
Quality of Life questionnaire, computer analysis of voice, trained listener analysis of voice [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00637416 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Dysphonia
  • Drug: Lansoprazole
    Lansoprazole 30 mg taken by mouth daily for 3 months
    Other Name: Prevacid
  • Other: Placebo
    placebo taken by mouth daily for 3 months
  • Active Comparator: Lansoprazole and dietary control
    Lansoprazole and dietary control
    Intervention: Drug: Lansoprazole
  • Placebo Comparator: Placebo and dietary control
    Dietary control and placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
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 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.
Sexes Eligible for Study: All
3 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00637416
10720
No
Not Provided
Not Provided
University of Kansas Medical Center
University of Kansas Medical Center
TAP Pharmaceutical Products Inc.
Principal Investigator: Julie Wei University of Kansas Medical Center
University of Kansas Medical Center
November 2016

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