Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849AM4)(COMPLETED)

This study has been completed.

Study NCT00536380 Information provided by Schering-Plough

First Received on September 26, 2007. Last Updated on April 8, 2010 History of Changes

Results First Received: February 24, 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:	Chronic Idiopathic Urticaria
Interventions:	Drug: 5-mg Desloratadine Drug: 10-mg Desloratadine Drug: 20-mg Desloratadine

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
5-mg Desloratadine	5-mg Desloratadine once daily
10-mg Desloratadine	10-mg Desloratadine once daily
20-mg Desloratadine	20-mg Desloratadine once daily

Participant Flow: Overall Study

	5-mg Desloratadine	10-mg Desloratadine	20-mg Desloratadine
STARTED	106	104	104
COMPLETED	94	95	94
NOT COMPLETED	12	9	10
Adverse Event	0	2	2
Lost to Follow-up	0	0	1
Withdrawal unrelated to study drug	2	0	1
Withdrawal related to study drug	7	5	2
Noncompliance with protocol	3	2	2
Did not meet protocol eligibility	0	0	1
Administrative	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
5-mg Desloratadine	5-mg Desloratadine once daily
10-mg Desloratadine	10-mg Desloratadine once daily
20-mg Desloratadine	20-mg Desloratadine once daily

Baseline Measures

	5-mg Desloratadine	10-mg Desloratadine	20-mg Desloratadine	Total
Number of Participants [units: participants]	106	104	104	314
Age [units: years] Mean ± Standard Deviation	41.4 ± 12.8	40.4 ± 13.3	40.1 ± 14.2	40.6 ± 13.4
Gender [units: participants]
Female	70	69	70	209
Male	36	35	34	105

Outcome Measures

1. Primary:

Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg [ Time Frame: Baseline and 4 treatment weeks ]

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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: PI agrees not to publish or publicly present any interim results of Study without prior written consent of sponsor. PI further agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation to permit sponsor to review copies of abstracts or manuscripts for publication (including, without limitation, slides and text of oral or other public presentations and text of any transmission through any electronic media) which report any results of Study.

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
Due to poor enrollment (even after extending the enrollment period), only 314 participants (not 600 participants) were randomized to the study and hence the study was inconclusive due to the lacking of statistical power and robustness.

Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00536380 History of Changes
Other Study ID Numbers:	P04849
Study First Received:	September 26, 2007
Results First Received:	February 24, 2010
Last Updated:	April 8, 2010
Health Authority:	Germany: German Health Authority