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.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00619801
First received: February 11, 2008
Last updated: August 30, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis Chronic Urticaria |
Drug: Levocetirizine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]The RR interval refers to the respective time interval in the Electrocardiogram (ECG).
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]The PR interval refers to the respective time interval in the Electrocardiogram (ECG).
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
- 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 ] [ Designated as safety issue: No ]The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
- Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) [ Time Frame: 7 days ] [ Designated as safety issue: No ]The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
- 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 ] [ Designated as safety issue: No ]The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Secondary Outcome Measures:
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
- Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 173 |
| Study Start Date: | March 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
|
| Experimental: Levocetirizine |
Drug: Levocetirizine
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
Other Name: Xyzal
|
Eligibility| Ages Eligible for Study: | 2 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatient, male or female pediatric subject, ages 1 to less than 6 years old at the Randomization Visit (V2) (1 - <6 years old)
- The subject must present at least one of the following symptoms, most commonly associated with allergic rhinitis or chronic urticaria: nasal itching, sneezing, rhinorrhea, nasal congestion, tearing, eye redness and itching of eyes, ears and/or palate, skin wheals and itching of the skin.
- Subjects (age 2 to less than 6 years only) suffering from AR should have a documented allergy measured by positive skin prick test or RAST (Radioallergosorbent Test) performed within the last 6 months prior to randomization.
- Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting.
- Caregiver(s) have been informed of the nature and aims of the study and have given their written informed consent for the subject to participate in this study.
- Caregivers(s) able to understand information given, the text of the informed consent, and be able to complete the daily record card (DRC).
Exclusion Criteria:
- Any clinically significant medical condition or abnormality other than the primary diagnosis for which an antihistamine is indicated.
- Be initiating or changing the dose of an immunotherapy regimen during the course of the study (visit 1 to Visit 4).
- Any ECG parameters, including a QTcF interval > 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619801
Show 28 Study Locations
Show 28 Study LocationsSponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided by UCB, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by UCB, Inc.:
|
Xyzal Levocetirizine Allergy Children Seasonal Allergies |
Additional relevant MeSH terms:
|
Rhinitis Urticaria Stress, Psychological Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Behavioral Symptoms |
Levocetirizine Cetirizine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013