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Study to Evaluate Diphenhydramine in Children and Adolescents
This study has been completed.
First Received: September 26, 2008   Last Updated: June 3, 2009   History of Changes
Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by: Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00762749
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
Drug: diphenhydramine HCl
Phase I

Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Diphenhydramine in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: predose (0), and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 24 hours after the dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
diphenhydramine HCl: Experimental
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

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

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762749

Locations
United States, Arkansas
Arkansas Medical Research Testing Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Johnson & Johnson Consumer & Personal Products Worldwide
Investigators
Study Director: Cathy M Gelotte, PhD McNeil Consumer Healthcare, Division of McNEIL-PPC
  More Information

No publications provided

Responsible Party: J&J CPPW ( Joyce Hauze/Senior Project Manager )
Study ID Numbers: DPHNCO1003
Study First Received: September 26, 2008
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00762749     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiemetics
Anesthetics
Rhinitis
Promethazine
Respiratory Tract Infections
Respiratory Tract Diseases
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics
Dermatologic Agents
Otorhinolaryngologic Diseases
Gastrointestinal Agents
Histamine Agents
Central Nervous System Depressants
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases
Anesthetics, Local
Histamine Antagonists
Autonomic Agents
Histamine H1 Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Diphenhydramine

ClinicalTrials.gov processed this record on February 08, 2010