Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
This study has been terminated.
Sponsor:
University of Kansas
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
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study 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:
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 ]
| Enrollment: | 13 |
| 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: 1
Lansoprazole and dietary control
|
Drug: Lansoprazole
Lansoprazole 30 mg PO daily for 3 months
Other Name: Prevacid
|
|
Placebo Comparator: 2
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:
- 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 PPI 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.
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: | Julie Wei, MD, Associate Professor, ENT, University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00637416 History of Changes |
| Other Study ID Numbers: | 10720 |
| Study First Received: | March 10, 2008 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
dysphonia |
Additional relevant MeSH terms:
|
Hoarseness Dysphonia Voice Disorders Laryngeal Diseases Respiratory Tract Diseases Respiration Disorders Otorhinolaryngologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Signs and Symptoms, Respiratory Lansoprazole Proton Pump Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013