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

Condition(s) targeted: Perennial Allergic Rhinitis

Intervention: loratadine (Drug); loratadine (Drug); loratadine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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.

Official title: Protocol for Post-Approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Primary outcome: The population PK parameters, estimated from SCH 29851 (unchanged drug), SCH 34117 (active metabolite), and SCH 45581 (3-OH-SCH 34117).

Secondary outcome:

PK parameters and plasma concentrations of SCH 34117 (the active metabolite) between the 3 age groups (3-6 years old, 7-15 years old, and 16-64 years old).

Change from baseline in score of 4 nasal symptoms

Incidence of adverse drug reactions.

Minimum age: 3 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with confirmed diagnosis of perennial allergic rhinitis, between the ages of

3 and 64 years of age, outpatients of either sex, patients with appropriate written informed consent and ability to perform the tasks required for the study, patients for whom treatment with loratadine is appropriate based on symptoms of perennial allergic rhinitis

Exclusion Criteria:

- Patients with history of epileptic seizures or organic brain dysfunction in whom there

is a possibility that epileptic seizures may be induced, patients with a history of hypersensitivity to the drug or component of the drug, patients who are pregnant, nursing or intending to become pregnant, patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications or poor condition, patients participating in another clinical study within the past 30 days, patients otherwise judged inappropriate by the investigator.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 5, Fukuoka, Japan; Recruiting

Starting date: June 2008
Ending date: December 2008
Last updated: October 29, 2008