The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

This study has been completed.

Study NCT00359138 Information provided by Schering-Plough

First Received on July 31, 2006. Last Updated on December 17, 2010 History of Changes

Results First Received: May 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hypersensitivity
Interventions:	Drug: desloratadine Drug: levocetirizine Drug: Desloratadine placebo tablet Drug: Levocetirizine placebo capsule

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
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

Participant Flow: Overall Study

	Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
STARTED	12	12	12
COMPLETED	12	12	12
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

Baseline Measures

	Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule	Total
Number of Participants [units: participants]	12	12	12	36
Age [units: years] Mean ± Standard Deviation	23.42 ± 4.91	28.33 ± 8.69	28.83 ± 11.55	26.86 ± 8.91
Gender [units: participants]
Female	5	8	5	18
Male	7	4	7	18

Outcome Measures

1. Primary:

Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment [ Time Frame: Starting at Day 8 ]

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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.

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:	NCT00359138 History of Changes
Other Study ID Numbers:	P04441
Study First Received:	July 31, 2006
Results First Received:	May 27, 2010
Last Updated:	December 17, 2010
Health Authority:	European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency