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

Merck Sharp & Dohme LLC1,003 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,003

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric patients aged 3 to 15 years who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous) Exclusion Criteria: * (None)

Outcomes

Primary Outcomes

Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies

Time frame: During and at the end of the observation period

Allergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching)

Time frame: Before the start of treatment, during the observation period, and at the end of the observation period

Urticaria, eczema, dermatitis, pruritus cutaneous: severity score of itching

Time frame: Before the start of treatment, during the observation period, and at the end of the observation period

Secondary Outcomes

Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable

Time frame: At the end of the observation period

Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable

Time frame: At the end of the observation period