Phenylephrine Pediatric Pharmacokinetic Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00762567
First received: September 26, 2008
Last updated: October 4, 2011
Last verified: October 2011
  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 1

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762567

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Dolly Parasrampuria, PhD McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and 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

Additional relevant MeSH terms:
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
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014