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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:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00637416
First received: March 10, 2008
Last updated: November 29, 2016
Last verified: November 2016
  Purpose
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.

Condition Intervention Phase
Dysphonia
Drug: Lansoprazole
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in Condition Over Treatment Period [ Time Frame: 3 months ]
    Change measured using voice assessment protocol—Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).


Enrollment: 9
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lansoprazole and dietary control
Lansoprazole and dietary control
Drug: Lansoprazole
Lansoprazole 30 mg taken by mouth daily for 3 months
Other Name: Prevacid
Placebo Comparator: Placebo and dietary control
Dietary control and placebo
Other: Placebo
placebo taken by mouth daily for 3 months

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical Center
TAP Pharmaceutical Products Inc.
Investigators
Principal Investigator: Julie Wei University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00637416     History of Changes
Other Study ID Numbers: 10720
Study First Received: March 10, 2008
Results First Received: October 5, 2016
Last Updated: November 29, 2016

Keywords provided by University of Kansas Medical Center:
horseness

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

ClinicalTrials.gov processed this record on March 24, 2017