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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762983
• Other study ID #: P05834
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: February 12, 2015
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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)

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• loratadine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies		During and at the end of the observation period	Yes
Primary	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	No
Primary	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	No
Secondary	Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable		At the end of the observation period	No
Secondary	Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable		At the end of the observation period	No