Phase 3
Completed N=173
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
Source: ClinicalTrials.gov NCT00619801 ↗Enrolled (actual)
173
Serious AEs
0.6%
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) — -1.5; 1.3 beats per minute
Summary
The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) |
-1.5; 1.3 | — |
| PRIMARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval |
9.2; -6.9 | — |
| PRIMARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval |
0.5; -0.8 | — |
| PRIMARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration |
0.3; 0.9 | — |
| PRIMARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval |
-2.8; -1.5 | — |
| 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) |
-5.5; -0.3 | — |
| PRIMARY Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) |
372.6; 368.9 | — |
| 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) |
369.8; 370.5 | — |
| SECONDARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin |
0.000; 0.000 | — |
| SECONDARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) |
-1.5; 1.0 | — |
| SECONDARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) |
-1.0; 1.0 | — |
| SECONDARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen |
-0.1785; 0.0000 | — |
| SECONDARY Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine |
-0.8840; 1.7680 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient, male or female pediatric subject, ages 1 to less than 6 years old at the Randomization Visit (V2) (1 - 443 msec measured by an ECG obtained at the Screening Visit, outside the normal reference ranges
- Any clinical laboratory tests performed at the Screening Visit, other than those related with the allergic condition, outside the reference ranges. Subjects having values outside the accepted reference range can be included if in the Investigator's opinion, they are of no clinical significance
- Personal history of seizure, febrile seizure or sleep apnea
- Below the lower 5th or above 95th percentile for body weight and/or height based upon CDC Growth Charts for Body Weight and Length
- Allergy or intolerance to levocetirizine dihydrochloride or its excipients, or to any other piperazine derivatives, such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine
- Current or past intake of the following medications (including exposure through breast milk) within the specified wash-out period before the Randomization Visit (V2):
- Systemic corticosteroids within the past 28 days
- Leukotriene-receptor antagonists (e.g. montelukast [Singulair] or zafirlukast [Accolate] within the past 7 days)
- Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days
- Other antihistamines or cough and cold preparations (with the exception of single ingredient guaifenesin products) or over-the-counter (OTC) sleep aid medications within the past 7 days
- Systemic antibiotics within the past 7 days
- Other concomitant medications that will interfere with the study, in the opinion of the investigator
- Previous participation in another clinical/pharmacological trial within the past month prior to V1
- Have already participated in this study or participated in this study at another site
- Children of any member of the study site staff
Data sourced from ClinicalTrials.gov (NCT00619801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.