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

This study has been completed.

Study NCT00406783 Information provided by Schering-Plough

First Received: November 29, 2006 Last Updated: September 25, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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

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 [ 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 [ 15 days ]

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Measure Type	Secondary
Measure Title	Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit
Measure Description	The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.
Time Frame	15 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.

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

Measured Values

	5-mg Desloratadine Tablet	Placebo Tablet
Number of Participants Analyzed [units: participants]	250	248
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit [units: scores on a scale] Least Squares Mean ± Standard Error	-1.1 ± 0.1	-0.73 ± 0.1

Statistical Analysis 1 for Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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3. Other Pre-specified:

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

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4. Other Pre-specified:

Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE [ 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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04683
Study First Received:	November 29, 2006
Results First Received:	November 21, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00406783 History of Changes
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment