Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)(COMPLETED) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: loratadine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Protocol for Post-approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients

Resource links provided by NLM:

Drug Information available for: Loratadine

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) [ Time Frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed ] [ Designated as safety issue: No ]
SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.
Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) [ Time Frame: After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed ] [ Designated as safety issue: No ]
SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.

Enrollment:	261
Study Start Date:	June 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pediatrics 3 to 6 years Pediatrics 3 to 6 years	Drug: loratadine Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks Other Names: Claritin SCH 29851
Experimental: Pediatrics 7 to 15 years Pediatrics 7 to 15 years	Drug: loratadine loratadine 10 mg tablet once daily for 4 weeks Other Names: Claritin SCH 29851
Experimental: Adults 16 to 64 years Adults 16 to 64 years	Drug: loratadine loratadine 10 mg tablet once daily for 4 weeks Other Names: Claritin SCH 29851

Eligibility

Ages Eligible for Study:	3 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00730912 History of Changes
Other Study ID Numbers:	P05539
Study First Received:	August 6, 2008
Results First Received:	June 3, 2010
Last Updated:	September 14, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loratadine
Antipruritics

Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 22, 2013