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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00762983

Enrollment

1003

Registered

2008-09-30

Start date

2008-03-31

Completion date

2009-02-28

Last updated

2015-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGloratadine

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.

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 15 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies	During and at the end of the observation period
Allergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching)	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	Before the start of treatment, during the observation period, and at the end of the observation period

Secondary

Measure	Time frame
Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable	At the end of the observation period
Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable	At the end of the observation period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026