Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months (BALL)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00628108

First received: February 22, 2008

Last updated: August 30, 2011

Last verified: December 2009

History of Changes

Results First Received: September 9, 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 1.25 mg Other: 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
One subject was randomized to levocetirizine but received placebo; hence the number of subjects in both treatment groups in the Safety Population differs by 1 from the number of the subjects randomized (STARTED) to the respective treatment group. All results are presented for the safety population for which the subjects were analyzed as treated.

Reporting Groups

	Description
Placebo	Placebo (5 drops) dosed by mouth in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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	23	46 ^[1]
Safety Population	24	45 ^[2]
COMPLETED	22	43
NOT COMPLETED	1	3
Adverse Event	0	3
Withdrawal by Subject	1	0

[1]	One subject was randomized to levocetirizine but received placebo.
[2]	Subjects in the Safety Population were analyzed as treated.

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo (5 drops) dosed by mouth in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Total	Total of all reporting groups

Baseline Measures

	Placebo	Levocetirizine	Total
Number of Participants [units: participants]	24	45	69
Age [units: participants]
<=18 years	24	45	69
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: months] Mean ± Standard Deviation	9.03 ± 1.80	8.87 ± 1.63	8.93 ± 1.67
Gender [units: participants]
Female	13	17	30
Male	11	28	39
Region of Enrollment [units: participants]
United States	24	45	69

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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Measure Type	Primary
Measure Title	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
Measure Description	The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)
Time Frame	Baseline, 14 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.
Safety Population; only non-missing values were analyzed

Reporting Groups

	Description
Placebo	Placebo (5 drops) dosed by mouth in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

Measured Values

	Placebo	Levocetirizine
Number of Participants Analyzed [units: participants]	20	38
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration [units: milliseconds] Mean ± Standard Deviation	1.4 ± 6.4	0.3 ± 5.7

No statistical analysis provided for Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration

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 Aminontransferase (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
No text entered.

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:	NCT00628108 History of Changes
Other Study ID Numbers:	A00423, RPCE08K2403
Study First Received:	February 22, 2008
Results First Received:	September 9, 2009
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration

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