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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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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