Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00762983|
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : February 13, 2015
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.
|Condition or disease||Intervention/treatment|
|Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Urticaria Pruritus||Drug: loratadine|
|Study Type :||Observational|
|Actual Enrollment :||1003 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Pediatric patients who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous)
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.
Other Name: Claritin, SCH 29851
- 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 ]
- 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 ]