Study to Evaluate Diphenhydramine in Children and Adolescents
Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: diphenhydramine HCl (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide Official(s) and/or principal investigator(s):
Cathy M Gelotte, PhD, Study Director, Affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Summary
To characterize the pharmacokinetics of diphenhydramine in two pediatric populations:
children, ages 2 to < 12 years, and adolescents, ages 12 to < 18 years.
Clinical Details
Official title: An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Diphenhydramine in Children and Adolescents
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Pharmacokinetic parameters
Secondary outcome: Safety Assessments will consist of monitoring vital signs and all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Detailed description:
This study has an open-label, single-dose classical pharmacokinetic design with no
comparator treatment or group. Twenty-four (24) children, ages 2 to < 12 years, and 12
adolescents, ages 12 to < 18 years, with 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 children enrolled will range from 2 to < 6 years of
age.
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
90th percentile for age and gender.
- Subjects who have a history of allergic rhinitis and who are experiencing symptoms
due to hay fever or other upper respiratory allergies will be included.
- Subjects who do not use concurrent medications, except for low-dose inhaled
glucocorticosteroids for allergic rhinitis or mild concurrent asthma, if dose is
stabilized before entry in the study (ie, dose is not changed for 1 month prior to
entry or during the study), and inhaled short-acting beta-2 adrenergic agonists for
concomitant asthma, as needed;
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 diphenhydramine or EMLA cream.
- Have a known sensitivity or allergy to red dye.
- Have asthma symptoms at the time of study entry or requiring medications other than
allowed in Inclusion Criterion 4;
- Took any prescription (other than allowed in Inclusion Criterion 4) or
nonprescription medication, within seven days or five half-lives (whichever is
longer) before the study's start date.
- Took any herbal supplements or drank grapefruit juice with 28 days of the study's
start date.
- 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 contraception from at least three months prior
to the first dose of study medication until completion of follow-up procedures.
Locations and Contacts
Arkansas Medical Research Testing Center, Little Rock, Arkansas 72202, United States
Additional Information
Starting date: September 2008
Last updated: October 4, 2011
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