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

Protocol for Post-approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients

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.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: loratadine; Drug: loratadine

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 64 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pediatrics 3 to 6 years	Drug: loratadine; Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks; Other Names: Claritin; SCH 29851; Drug: loratadine; loratadine 10 mg tablet once daily for 4 weeks; Other Names: Claritin; SCH 29851
EXPERIMENTAL: Pediatrics 7 to 15 years	Drug: loratadine; Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks; Other Names: Claritin; SCH 29851; Drug: loratadine; loratadine 10 mg tablet once daily for 4 weeks; Other Names: Claritin; SCH 29851
EXPERIMENTAL: Adults 16 to 64 years	Drug: loratadine; Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks; Other Names: Claritin; SCH 29851; Drug: loratadine; loratadine 10 mg tablet once daily for 4 weeks; Other Names: Claritin; SCH 29851

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)	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.	After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed
Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)	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.	After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: August 6, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (ESTIMATE): August 8, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Loratadine
• Other Study ID Numbers: P05539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

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