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| Sponsor: | Johnson & Johnson Consumer & Personal Products Worldwide |
|---|---|
| Information provided by (Responsible Party): | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00762567 |
Purpose
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis |
Drug: phenylephrine HCl |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents |
| Enrollment: | 36 |
| Study Start Date: | September 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
phenylephrine
|
Drug: phenylephrine HCl
A single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
Other Name: Children's Sudafed PE Nasal Decongestant Liquid
|
This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. At least twenty-four (24) children, ages 2 to <12 years, and twelve (12) adolescents, ages 12 to <18 years, with nasal symptoms due to hay fever or other upper respiratory allergies will complete the study. To ensure that younger children are represented, at least 35% (8) of the 24 children enrolled will range from 2 to <6 years of age.
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| West Coast Clinical Trials | |
| Cypress, California, United States, 90630 | |
| Study Director: | Dolly Parasrampuria, PhD | McNeil Consumer Healthcare, Division of McNEIL-PPC |
More Information
| Responsible Party: | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00762567 History of Changes |
| Other Study ID Numbers: | PHEALY1006 |
| Study First Received: | September 26, 2008 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Nasal Decongestants Phenylephrine Oxymetazoline Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents |
Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiotonic Agents Mydriatics Autonomic Agents Peripheral Nervous System Agents Sympathomimetics Protective Agents |