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Phenylephrine Pediatric Pharmacokinetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762567
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 6, 2011
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Brief Summary:
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.

Condition or disease Intervention/treatment Phase
Rhinitis Drug: phenylephrine HCl Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents
Study Start Date : September 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Pharmacokinetic Parameters [ Time Frame: 10, 20, 30, 45, and 60 minutes, and at 1.5, 2, 2.5, 3, and 3.5 hours after the dose. For children >6, an additional blood sample will be collected at 4.5 hours after dosing ]

Secondary Outcome Measures :
  1. For children 5 years and older and adolescents, the total amount of phenylephrine and its metabolites excreted, percent of the administered dose will be estimated from the urine samples along with the formation clearance of each metabolite. [ Time Frame: 24 hours ]
  2. Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product. [ Time Frame: throughout duration of the study + 2 days (+30 days for spontaneously reported SAEs) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female children and adolescents, ages 2 to < 18 years, with a minimum weight of 24 pounds will be eligible to participate. In addition, each subject will be > 5th percentile and < 95th percentile for weight based on age and gender.
  • Subjects will have a body mass index (BMI) > 5th percentile and less than or equal to the 90th percentile for age and gender.
  • Subjects who have a history of allergic rhinitis and who are experiencing nasal symptoms associated with hay fever or other upper respiratory allergies will be included.
  • Subjects and parents or legally authorized representatives who, in the investigator's view, are likely to be compliant and complete the study will be eligible to participate.
  • Post menarchal female subjects must have a negative urine pregnancy test at screening and at Visit 2 on Day 1 before study medication is administered.
  • Post menarchal female subjects must have practiced abstinence or use an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least three months before being enrolled in the study.
  • Parents or legally authorized representatives have signed and dated an IRB-approved consent form for the subject to participate in the study indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • Subjects, ages 6 to < 18 years, who have provided written assent to participate in the study

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease.
  • Findings from the medical history or physical examination with vital sign measurements that are not within the range of clinical acceptability.
  • Have a known sensitivity or allergy to phenylephrine or EMLA cream.
  • Took any prescription or nonprescription medication (except vitamins and/or fluoride supplements) within seven days before the study's start date.
  • Drank any fruit juices (i.e., apple, orange, or grapefruit) within two days prior to the study start.
  • Use of any monoamine oxidase inhibitor within two weeks prior to the dose of phenylephrine.
  • Participated in, or completed, another clinical trial within seven weeks before the study's start date.
  • Have a history of drug, alcohol, and tobacco use (older children and adolescents).
  • Have a history of hepatitis B, a previous positive test for hepatitis B surface antigen, or a previous positive hepatitis C antibody.
  • Have a history of HIV infection or previous demonstration of HIV antibodies.
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least three months prior to the first dose of study medication until completion of follow-up procedures.
  • Relationship to persons involved directly with the conduct of the study (ie, principal investigator; subinvestigators; study coordinators; other study personnel; employees or contractors of the sponsor or its subsidiaries; and the families of each).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762567

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United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
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Study Director: Dolly Parasrampuria, PhD McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
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Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide Identifier: NCT00762567    
Other Study ID Numbers: PHEALY1006
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Nasal Decongestants
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents