Study to Evaluate Diphenhydramine in Children and Adolescents

Completed · Phase 1

Conditions studied: Allergic Rhinitis

In brief

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

Key facts

Study ID

NCT00762749

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

36

Starts

2008-09-01

Expected to finish

2008-11-01

Last updated by the study team

2011-10-06

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Arkansas Medical Research Testing Center — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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