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

Condition(s) targeted: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria; Pruritus

Intervention: loratadine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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.

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

Study design: Ecologic or Community, Prospective

Primary outcome:

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

Allergic 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, Unassessable

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

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)

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Coordinating Location, Osaka, Japan; Recruiting

Starting date: March 2008
Ending date: June 2009
Last updated: January 28, 2009