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| Sponsor: | University of Kansas |
|---|---|
| Collaborator: |
TAP Pharmaceutical Products Inc. |
| Information provided by: | University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00637416 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Lansoprazole and dietary control
|
Drug: Lansoprazole
Lansoprazole 30 mg PO daily for 3 months
|
|
2: Placebo Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Julie Wei | University of Kansas |
More Information
| Responsible Party: | University of Kansas Medical Center ( Julie Wei ) |
| Study ID Numbers: | 10720 |
| Study First Received: | March 10, 2008 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00637416 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
dysphonia |
|
Anti-Infective Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Hoarseness Respiration Disorders Nervous System Diseases Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions Signs and Symptoms |
Respiratory Tract Diseases Proton Pump Inhibitors Therapeutic Uses Anti-Ulcer Agents Neurologic Manifestations Signs and Symptoms, Respiratory Voice Disorders Laryngeal Diseases Lansoprazole |