Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)

NCT ID: NCT00730912

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-12-31

Brief Summary

This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.

Conditions

Perennial Allergic Rhinitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pediatrics 3 to 6 years

Pediatrics 3 to 6 years

Group Type: EXPERIMENTAL

loratadine

Intervention Type: DRUG

Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks

Pediatrics 7 to 15 years

Pediatrics 7 to 15 years

Group Type: EXPERIMENTAL

loratadine

Intervention Type: DRUG

loratadine 10 mg tablet once daily for 4 weeks

Adults 16 to 64 years

Adults 16 to 64 years

Group Type: EXPERIMENTAL

loratadine

Intervention Type: DRUG

loratadine 10 mg tablet once daily for 4 weeks

Interventions

loratadine

Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks

Intervention Type: DRUG

loratadine

loratadine 10 mg tablet once daily for 4 weeks

Intervention Type: DRUG

loratadine

loratadine 10 mg tablet once daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Claritin; SCH 29851; Claritin; SCH 29851; Claritin; SCH 29851

Eligibility Criteria

Inclusion Criteria

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

• Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
• Outpatients of either sex.
• Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
• Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
• Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
• Patients confirmed to be allergic to perennial allergen

Exclusion Criteria

• Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
• Patients with a history of hypersensitivity to any component of this drug
• Patients who are pregnant or who may be pregnant, and nursing women
• Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
• Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
• Other patients judged inappropriate for study by the investigator or sub-investigator
• Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
• Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
• Patients who received treatment for allergic rhinitis in the 7 days before registration

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05539

Identifier Type: -

Identifier Source: org_study_id