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Study to Evaluate Diphenhydramine in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00762749
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 6, 2011
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: diphenhydramine HCl Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: predose (0), and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 24 hours after the dose ]

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

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United States, Arkansas
Arkansas Medical Research Testing Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
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Study Director: Cathy M Gelotte, PhD McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
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Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00762749    
Other Study ID Numbers: DPHNCO1003
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Rhinitis, Allergic
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents