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Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)(COMPLETED)
This study has been completed.
Study NCT00730912   Information provided by Schering-Plough
First Received: August 6, 2008   Last Updated: January 28, 2009   History of Changes

August 6, 2008
January 28, 2009
June 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00730912 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)(COMPLETED)
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.

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Perennial Allergic Rhinitis
Drug: loratadine
  • Experimental: Pediatrics 3 to 6 years
  • Experimental: Pediatrics 7 to 15 years
  • Experimental: Adults 16 to 64 years
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
250
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
3 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00730912
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
P05539
Schering-Plough
 
 
Schering-Plough
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP