NCT00762983

Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)

Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,003 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Conditions

• Rhinitis, Allergic, Seasonal
• Rhinitis, Allergic, Perennial
• Urticaria
• Pruritus

Interventions

Type	Name	Description
DRUG	loratadine	Claritin Tablet 10 mg, Claritin RediTabs 10 mg: For pediatric patients aged 7 years and older, 10 mg of loratadine is orally administered once daily after a meal in usual cases. Claritin Dry Syrup 1%: For pediatric patients aged 3 to \< 7 years, 5 mg loratadine (0.5 g dry syrup); and for pediatric patients aged 7 years and older, 10 mg of loratadine (1 g dry syrup) is dissolved immediately before use and orally administered once daily after a meal in usual cases. The observation period will not be specified.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-09-30
• Last updated: 2015-02-13