Study to Evaluate Diphenhydramine in Children and Adolescents

NCT00762749 | Completed Phase 1

• 1 other identifier: DPHNCO1003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters

  predose (0), and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 24 hours after the dose

Secondary Outcomes (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.

  throughout duration of the study + 2 days (+ 30 days for spontaneously reported SAEs)

Study Arms (1)

diphenhydramine HCl

EXPERIMENTAL

diphenhydramine HCl / Children's Benadryl Allergy Liquid

Drug: diphenhydramine HCl

Interventions

diphenhydramine HCl DRUG

A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight dosing schedule

Also known as: Children's Benadryl Allergy Liquid

diphenhydramine HCl

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

Arkansas Medical Research Testing Center

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Cathy M Gelotte, PhD

  McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

US (1)