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 on August 6, 2008. Last Updated on September 14, 2010 History of Changes

Results First Received: June 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Perennial Allergic Rhinitis
Intervention:	Drug: loratadine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pediatrics 3 to 6 Years	Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
Pediatrics 7 to 15 Years	Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
Adults 16 to 64 Years	Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days

Participant Flow: Overall Study

	Pediatrics 3 to 6 Years	Pediatrics 7 to 15 Years	Adults 16 to 64 Years
STARTED	53	104	104
COMPLETED	53	104	103
NOT COMPLETED	0	0	1
Discontinued	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Pediatrics 3 to 6 Years	Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
Pediatrics 7 to 15 Years	Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
Adults 16 to 64 Years	Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days

Baseline Measures

	Pediatrics 3 to 6 Years	Pediatrics 7 to 15 Years	Adults 16 to 64 Years	Total
Number of Participants [units: participants]	53	104	104	261
Age, Customized [units: participants]
Between 3-6 years	53	0	0	53
Between 7 and 15 years	0	104	0	104
Between 16 - 64 years	0	0	104	104
Gender [units: participants]
Female	16	29	68	113
Male	37	75	36	148

Outcome Measures

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1. Primary:

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 ]

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2. Primary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

The investigator (sub-investigator) will disclose the results and knowledge obtained through this study after discussion with the Sponsor and approval is obtained from the Sponsor.

If the investigator (sub-investigator) is to present the results obtained from this study at a medical conference or medical journal, approval of the Sponsor must be obtained beforehand

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

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