- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00762567
Phenylephrine Pediatric Pharmacokinetic Study
October 4, 2011 updated by: Johnson & Johnson Consumer and Personal Products Worldwide
An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Cypress, California, United States, 90630
- West Coast Clinical Trials
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
phenylephrine
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A single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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24 hours
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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)
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throughout duration of the study + 2 days (+30 days for spontaneously reported SAEs)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
September 26, 2008
First Submitted That Met QC Criteria
September 26, 2008
First Posted (ESTIMATE)
September 30, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Nose Diseases
- Rhinitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
- Nasal Decongestants
Other Study ID Numbers
- PHEALY1006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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