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| Sponsor: | Johnson & Johnson Consumer & Personal Products Worldwide |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Diphenhydramine in Children and Adolescents |
| 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 |
|---|---|
|
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00762749 History of Changes |
| Other Study ID Numbers: | DPHNCO1003 |
| Study First Received: | September 26, 2008 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Diphenhydramine Promethazine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Anesthetics Sensory System Agents Antipruritics Dermatologic Agents |