A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

This study has been completed.

Study NCT00621959 Information provided by UCB, Inc.

First Received on February 11, 2008. Last Updated on August 30, 2011 History of Changes

Results First Received: June 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Seasonal Allergic Rhinitis
Interventions:	Drug: levocetirizine dihydrochloride 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
Placebo	Matched placebo tablets once daily
LCTZ	5 mg levocetirizine dihydrochloride tablet once daily

Participant Flow: Overall Study

	Placebo	LCTZ
STARTED	295 ^[1]	301
COMPLETED	288	292
NOT COMPLETED	7	9
Adverse Event	4	2
Lack of Efficacy	1	1
Lost to Follow-up	0	2
Withdrawal by Subject	1	1
Unknown	1	3

[1]	In all 791 subjects have been screened and 596 have been randomized

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Matched placebo tablets once daily
LCTZ	5 mg levocetirizine dihydrochloride tablet once daily

Baseline Measures

	Placebo	LCTZ	Total
Number of Participants [units: participants]	295	301	596
Age [units: years] Mean ± Standard Deviation	37.36 ± 11.05	37.02 ± 11.99	37.18 ± 11.52
Gender [units: participants]
Female	199	206	405
Male	96	95	191
Region of Enrollment [units: participants]
United States	295	301	596

Outcome Measures

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1. Primary:

Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) [ Time Frame: Over the total treatment period (14 days) ]

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2. Secondary:

Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score [ Time Frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days) ]

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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: UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

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: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493

No publications provided by UCB, Inc.

Publications automatically indexed to this study:

Segall N, Gawchik S, Georges G, Haeusler JM. Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study. Ann Allergy Asthma Immunol. 2010 Mar;104(3):259-67.

Mansfield LE, Hampel F, Haeusler JM, Georges G. Study of levocetirizine in seasonal allergic rhinitis. Curr Med Res Opin. 2010 Jun;26(6):1269-75.

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00621959 History of Changes
Other Study ID Numbers:	A00430
Study First Received:	February 11, 2008
Results First Received:	June 18, 2009
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration