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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00762983

Purpose

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.

Condition	Intervention
Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Urticaria Pruritus	Drug: loratadine

Study Type:	Observational
Study Design:	Ecologic or Community, Prospective
Official Title:	Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)

Resource links provided by NLM:

MedlinePlus related topics: Children's Health Eczema Hay Fever Hives Itching

Drug Information available for: Loratadine

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable [ Time Frame: At the end of the observation period ] [ Designated as safety issue: No ]
Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable [ Time Frame: At the end of the observation period ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	720
Study Start Date:	March 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 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)	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.

Groups/Cohorts

Assigned Interventions

Group 1

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)

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.

Eligibility

Ages Eligible for Study:	3 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pediatric patients who are treated with Claritin at a department of pediatrics, department of otorhinology, department of dermatology, etc. at approximately 120 institutions

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05834
Study First Received:	September 29, 2008
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00762983 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Pruritus
Skin Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Signs and Symptoms
Hypersensitivity
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Loratadine
Therapeutic Uses
Antipruritics
Dermatologic Agents

Skin Diseases, Vascular
Otorhinolaryngologic Diseases
Skin Diseases
Immune System Diseases
Histamine Agents
Urticaria
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010