Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

Status Completed

Clinical Trial Summary

The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00796315
Study type	Interventional
Source	Procter and Gamble
Contact
Status	Completed
Phase	Phase 1
Start date	December 2008
Completion date	June 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05080322` - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis	Phase 4
Recruiting	`NCT06028490` - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.	Phase 2
Completed	`NCT04388358` - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation	N/A
Recruiting	`NCT04202263` - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline	Phase 2
Completed	`NCT04078009` - Standardising Nasal Allergen Challenge in Adult With Hay Fever	N/A
Completed	`NCT03644680` - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study	N/A
Completed	`NCT04541004` - Adolescent Mite Allergy Safety Evaluation	Phase 3
Recruiting	`NCT05378594` - HDM and Silver Birch NAC Standardisation	N/A
Not yet recruiting	`NCT05684380` - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)	Phase 3
Completed	`NCT02910401` - Clinical Response to Rhinovirus Challenge	Phase 2
Completed	`NCT02943720` - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen	Phase 2
Not yet recruiting	`NCT01014325` - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy	Phase 3
Completed	`NCT02556801` - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy	Phase 2
Completed	`NCT02352168` - Airway Inflammation in Children With Allergic Rhinitis and Intervention	N/A
Not yet recruiting	`NCT02233426` - Effect of Hypertonic Solutions on Allergic Rhinitis Patients	N/A
Completed	`NCT01918956` - PURETHAL Birch RUSH Study	Phase 4
Completed	`NCT01946035` - Alpha-Blockers in Allergic Rhinitis (MAN 01)	Phase 4
Completed	`NCT01682070` - SUBLIVAC FIX Phleum Pratense DT/DRF	Phase 2
Recruiting	`NCT01454492` - The Relationship Between Allergic Rhinitis and Geographic Tongue	N/A
Completed	`NCT01438463` - PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis	Phase 2