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
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
No text entered.

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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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.
No text entered.

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 ]

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

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

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

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

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 ]

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 ]

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 ]

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

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 ]

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 ]

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 ]

13.  Secondary:   Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine   [ Time Frame: Baseline, 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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:

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