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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00730912

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
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:

The population PK parameters, estimated from SCH 29851 (unchanged drug), SCH 34117 (active metabolite), and SCH 45581 (3-OH-SCH 34117). [ Time Frame: after 1, 2, 3, and 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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). [ Time Frame: after 1, 2, 3, and 4 weeks of treatment. ] [ Designated as safety issue: No ]
Change from baseline in score of 4 nasal symptoms [ Time Frame: after 2 and 4 weeks of treatment ] [ Designated as safety issue: No ]
Incidence of adverse drug reactions. [ Time Frame: from start to end of treatment (after 4 weeks of treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
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
Pediatrics 3 to 6 years: Experimental Pediatrics 3 to 6 years	Drug: loratadine Loratadine (SCH 029851) dry syrup 1% 5 mg/day for 4 weeks
Pediatrics 7 to 15 years: Experimental Pediatrics 7 to 15 years	Drug: loratadine loratadine 10 mg tablet once daily for 4 weeks
Adults 16 to 64 years: Experimental Adults 16 to 64 years	Drug: loratadine loratadine 10 mg tablet once daily for 4 weeks

Eligibility

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05539
Study First Received:	August 6, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00730912 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Rhinitis
Anti-Allergic Agents
Histamine
Hypersensitivity
Histamine Antagonists
Rhinitis, Allergic, Perennial

Respiratory Tract Diseases
Respiratory Tract Infections
Loratadine
Hypersensitivity, Immediate
Histamine phosphate
Antipruritics
Histamine H1 Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases
Hypersensitivity
Histamine Antagonists

Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Loratadine
Therapeutic Uses
Hypersensitivity, Immediate
Histamine H1 Antagonists
Antipruritics
Histamine H1 Antagonists, Non-Sedating
Dermatologic Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009