Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683AM1)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00406783

First received: November 29, 2006

Last updated: September 25, 2009

Last verified: September 2009

History of Changes

Results First Received: November 21, 2008

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
Conditions:	Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial
Interventions:	Drug: 5-mg Desloratadine Drug: Placebo

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 Tablet	5 mg desloratadine tablet, once daily for 15 days
Placebo Tablet	placebo tablet, once daily for 15 days

Participant Flow: Overall Study

	5-mg Desloratadine Tablet	Placebo Tablet
STARTED	276	271
COMPLETED	262	256
NOT COMPLETED	14	15
Adverse Event	4	4
Treatment Failure	2	3
Lost to Follow-up	3	0
Withdrawal by Subject	1	4
Protocol Violation	4	4

Baseline Characteristics

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Reporting Groups

	Description
5-mg Desloratadine Tablet	5 mg desloratadine tablet, once daily for 15 days
Placebo Tablet	placebo tablet, once daily for 15 days
Total	Total of all reporting groups

Baseline Measures

	5-mg Desloratadine Tablet	Placebo Tablet	Total
Number of Participants [units: participants]	276	271	547
Age [units: years] Mean ± Standard Deviation	33.8 ± 12.0	34.6 ± 12.8	34.2 ± 12.4
Gender [units: participants]
Female	154	164	318
Male	122	107	229

Outcome Measures

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1. Primary:

The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 [ Time Frame: 15 days ]

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2. Secondary:

Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit [ Time Frame: 15 days ]

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3. Other Pre-specified:

Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE [ Time Frame: Baseline ]

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4. Other Pre-specified:

Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE [ Time Frame: Baseline ]

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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 must provide sponsor w/ review copies of abstracts or manuscripts for publication that report any results of the study, 45 days before submission for publication or presentation. The sponsor shall have the right to review/comment on the material. If the parties disagree about the appropriateness of the material, PI must meet with sponsor's representatives before submission for publication, for the purpose of making good faith efforts to discuss and resolve any issues of disagreement.

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: 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:	NCT00406783 History of Changes
Other Study ID Numbers:	P04683
Study First Received:	November 29, 2006
Results First Received:	November 21, 2008
Last Updated:	September 25, 2009
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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