Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00762983
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.


Condition or disease Intervention/treatment
Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Urticaria Pruritus Drug: loratadine

Layout table for study information
Study Type : Observational
Actual Enrollment : 1003 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives Itching
Drug Information available for: Loratadine

Group/Cohort Intervention/treatment
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.

Other Name: Claritin, SCH 29851




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable [ Time Frame: At the end of the observation period ]
  2. Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable [ Time Frame: At the end of the observation period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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)

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00762983     History of Changes
Other Study ID Numbers: P05834
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Urticaria
Pruritus
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Respiratory Hypersensitivity
Loratadine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs