Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria; Pruritus
Intervention: loratadine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)
Study design: Observational Model: Ecologic or Community, Time Perspective: Prospective
Primary outcome: Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studiesAllergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching) Urticaria, eczema, dermatitis, pruritus cutaneous: severity score of itching
Secondary outcome: Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, UnassessableUrticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable
Eligibility
Minimum age: 3 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
Starting date: March 2008
Last updated: February 12, 2015
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