Study to Evaluate Diphenhydramine in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT00762749|
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 6, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: diphenhydramine HCl||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|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 Diphenhydramine in Children and Adolescents|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: diphenhydramine HCl
diphenhydramine HCl / Children's Benadryl Allergy Liquid
Drug: diphenhydramine HCl
A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight dosing schedule
Other Name: Children's Benadryl Allergy Liquid
- Pharmacokinetic parameters [ Time Frame: predose (0), and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 24 hours after the dose ]
- 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. [ Time Frame: throughout duration of the study + 2 days (+ 30 days for spontaneously reported SAEs) ]
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|Ages Eligible for Study:||2 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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;
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00762749
|United States, Arkansas|
|Arkansas Medical Research Testing Center|
|Little Rock, Arkansas, United States, 72202|
|Study Director:||Cathy M Gelotte, PhD||McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.|
|Responsible Party:||Johnson & Johnson Consumer and Personal Products Worldwide|
|Other Study ID Numbers:||
|First Posted:||September 30, 2008 Key Record Dates|
|Last Update Posted:||October 6, 2011|
|Last Verified:||October 2011|
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action