Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin - Study Results

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin (PAL)

This study has been completed.

Study NCT00619801 Information provided by UCB, Inc.

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

Results First Received: July 28, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Allergic Rhinitis Chronic Urticaria
Interventions:	Drug: Levocetirizine 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	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Participant Flow: Overall Study

	Placebo	Levocetirizine
STARTED	59	114
Safety Population	59	114
COMPLETED	58	111
NOT COMPLETED	1	3
Lack of Efficacy	0	1
Withdrawal by Subject	1	1
Loss of efficacy	0	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine	Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Baseline Measures

	Placebo	Levocetirizine	Total
Number of Participants [units: participants]	59	114	173
Age [units: participants]
<=18 years	59	114	173
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	3.75 ± 1.45	3.78 ± 1.38	3.77 ± 1.40
Gender [units: participants]
Female	23	49	72
Male	36	65	101
Region of Enrollment [units: participants]
United States	59	114	173

Outcome Measures

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1. Primary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) [ Time Frame: Baseline, 14 days ]

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2. Primary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval [ Time Frame: Baseline, 14 days ]

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3. Primary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval [ Time Frame: Baseline, 14 days ]

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4. Primary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration [ Time Frame: Baseline, 14 days ]

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5. Primary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval [ Time Frame: Baseline, 14 days ]

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6. Primary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) [ Time Frame: Baseline, 14 days ]

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7. Primary:

Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7) [ Time Frame: 7 days ]

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8. Primary:

Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) [ Time Frame: 14 days ]

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9. Secondary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin [ Time Frame: Baseline, 14 days ]

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10. Secondary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) [ Time Frame: Baseline, 14 days ]

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11. Secondary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 14 days ]

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12. Secondary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen [ Time Frame: Baseline, 14 days ]

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13. Secondary:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine [ Time Frame: Baseline, 14 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
phone: +1 877 822 9493

No publications provided by UCB, Inc.

Publications automatically indexed to this study:

Hampel F, Ratner P, Haeusler JM. Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria. Allergy Asthma Proc. 2010 Jul;31(4):290-5.

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00619801 History of Changes
Other Study ID Numbers:	A00426, RPCE07K2404
Study First Received:	February 11, 2008
Results First Received:	July 28, 2009
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration