Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: loratadine; loratadine; loratadine
Intervention description: Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks; loratadine 10 mg tablet once daily for 4 weeks; loratadine 10 mg tablet once daily for 4 weeks
Intervention MeSH terms: Loratadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 3 Years
Maximum age: 64 Years
Healthy volunteers: No

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.
    

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