Phenylephrine Pediatric Pharmacokinetic Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. At least twenty-four (24) children, ages 2 to <12 years, and twelve (12) adolescents, ages 12 to <18 years, with nasal 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 24 children enrolled will range from 2 to <6 years of age. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Rhinitis

Clinical Trial Details

NCT number	NCT00762567
Study type	Interventional
Source	Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status	Completed
Phase	Phase 1
Start date	September 2008
Completion date	November 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02340130` - Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma	Phase 2
Completed	`NCT02360072` - Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Completed	`NCT01118312` - Study of Asthma and Nasal Steroids	Phase 4
Completed	`NCT00541255` - A Long-Term Examination of Asthma From Childhood Through Adolescence
Completed	`NCT00279916` - Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays	Phase 3
Completed	`NCT00524836` - Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis	Phase 3
Completed	`NCT00963573` - Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)	Phase 4
Completed	`NCT00521131` - Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites	Phase 4
Completed	`NCT04132570` - A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution	Phase 4
Completed	`NCT02784262` - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis	Phase 2
Terminated	`NCT02630472` - Topical Irrigation Therapy for CRS	Phase 1/Phase 2
Completed	`NCT02596321` - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma	Phase 3
Completed	`NCT02279706` - Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test	N/A
Completed	`NCT01971086` - Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary	N/A
Completed	`NCT01771120` - Control and Burden of Asthma and Rhinitis	N/A
Completed	`NCT01469234` - A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)	Phase 4
Withdrawn	`NCT01177852` - Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis	Phase 3
Completed	`NCT00724698` - Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Completed	`NCT02879929` - Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction	N/A
Completed	`NCT02272101` - Rhinitis in the Elderly: The Role of Vitamin D	Phase 3