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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00796315 |
The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing OTC doses provide comparable systemic drug exposure as that associated with efficacy in adults.
Condition | Intervention | Phase |
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Allergic Rhinitis Upper Respiratory Infection |
Drug: Doxylamine Succinate USP |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Single-Dose, Open-Label, Multi-Center Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Ages 2 to < 18 Years |
Estimated Enrollment: | 44 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
See intervention
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Drug: Doxylamine Succinate USP
One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL
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Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
had a previous diagnosis of allergic rhinitis, or had a history of frequent upper respiratory infections (URI)/common cold and either be symptomatic, or at risk for future URI, including each of the following 3 criteria
Exclusion Criteria:
Contact: Peter R Thomas, BA | 513.622.4838 | thomas.pr@pg.com |
United States, District of Columbia | |
Dana Best, MD | |
Washington, District of Columbia, United States, 20010 | |
United States, Kentucky | |
Janice E. Sullivan, MD | |
Louisville, Kentucky, United States, 40202 | |
United States, Louisiana | |
Margaret Ann Springer, MD | |
Shreveport, Louisiana, United States, 71103 | |
United States, Missouri | |
Bridgette Jones, MD | |
Kansas City, Missouri, United States, 64108 | |
United States, North Carolina | |
Alex Kemper, Pharm D | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Jeffrey L Blumer, MD, PhD | |
Cleveland, Ohio, United States, 44106 |
Study Director: | Molly Seeck, BS, JD | Procter & Gamble Company |
Responsible Party: | Procter and Gamble Company ( Muhammad I Rehman, MD ) |
Study ID Numbers: | 2008014 |
Study First Received: | November 18, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00796315 |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetic study |
Doxylamine succinate Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Doxylamine Histamine phosphate Rhinitis Histamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Histamine Agents Antiemetics Infection Nose Diseases |
Pharmacologic Actions Histamine Antagonists Autonomic Agents Therapeutic Uses Histamine H1 Antagonists Peripheral Nervous System Agents Central Nervous System Agents |