- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00637416
Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
November 29, 2016 updated by: University of Kansas Medical Center
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 proton pump inhibitor 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lansoprazole and dietary control
|
Lansoprazole 30 mg taken by mouth daily for 3 months
Other Names:
|
Placebo Comparator: Placebo and dietary control
Dietary control and placebo
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placebo taken by mouth daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Condition Over Treatment Period
Time Frame: 3 months
|
Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julie Wei, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
March 10, 2008
First Submitted That Met QC Criteria
March 10, 2008
First Posted (Estimate)
March 18, 2008
Study Record Updates
Last Update Posted (Estimate)
January 23, 2017
Last Update Submitted That Met QC Criteria
November 29, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Signs and Symptoms, Respiratory
- Laryngeal Diseases
- Voice Disorders
- Dysphonia
- Hoarseness
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- 10720
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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