Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00628108
Other study ID # A00423
Secondary ID RPCE08K24032007-
Status Completed
Phase Phase 3
First received February 22, 2008
Last updated February 18, 2015
Start date March 2008
Est. completion date September 2008

Study information

Verified date February 2015
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 11 Months
Eligibility Inclusion Criteria:

- Outpatient, male or female pediatric subject, aged from 6 to 11 months (6 months - < 1 year) at the randomization visit

- The subject must present at least one symptom most commonly associated with allergic rhinitis or chronic idiopathic urticaria

- Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting

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 Electrocardiogram (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 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 (including exposure through breast milk) of the following medications 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

- Sibling with sleep apnea or sudden infant death syndrome (SIDS)

- Exposure to other conditions known to be potential risk factors for SIDS, such as but not limited to (this should be determined on a case by case basis taking into account the subject's entire medical history and environmental living conditions):

- Mothers who smoked or abused drugs during pregnancy

- Extremely young mothers (defined as age 19 or younger when pregnant)

- Children currently exposed to a caregiver which is a heavy cigarette smoker (defined as smoking at least a pack of cigarettes per day)

- Babies who sleep regularly on their face or are not put to sleep on their backs

- Premature birth gestational age = 37 weeks) or low birth weight (below 10 percentile for gestational age)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Levocetirizine 1.25 mg
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
Other:
Placebo
Placebo oral liquid once a day for two weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) Baseline, 14 days No
Primary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval The RR interval refers to the respective time interval in the Electrocardiogram (ECG) Baseline, 14 days No
Primary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval The PR interval refers to the respective time interval in the Electrocardiogram (ECG) Baseline, 14 days No
Primary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration The QRS duration refers to the respective time interval in the Electrocardiogram (ECG) Baseline, 14 days No
Primary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval The QT interval refers to the respective time in the Electrocardiogram (ECG) Baseline, 14 days No
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) The QT interval refers to the respective time interval in the Electrocardiogram (ECG) Baseline, 14 days No
Primary Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) The QT interval refers to the respective time interval in the Electrocardiogram (ECG) 7 days No
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) The QT interval refers to the respective time interval in the Electrocardiogram (ECG) 14 days No
Secondary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin Baseline, 14 days No
Secondary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) Baseline, 14 days No
Secondary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST) Baseline, 14 days No
Secondary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen Baseline, 14 days No
Secondary Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine Baseline, 14 days No
See also
  Status Clinical Trial Phase
Recruiting NCT05080322 - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis Phase 4
Recruiting NCT06028490 - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis. Phase 2
Completed NCT04388358 - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation N/A
Recruiting NCT04202263 - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline Phase 2
Completed NCT04078009 - Standardising Nasal Allergen Challenge in Adult With Hay Fever N/A
Completed NCT03644680 - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study N/A
Completed NCT04541004 - Adolescent Mite Allergy Safety Evaluation Phase 3
Recruiting NCT05378594 - HDM and Silver Birch NAC Standardisation N/A
Not yet recruiting NCT05684380 - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER) Phase 3
Not yet recruiting NCT01014325 - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy Phase 3
Completed NCT02910401 - Clinical Response to Rhinovirus Challenge Phase 2
Completed NCT02943720 - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen Phase 2
Completed NCT02556801 - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy Phase 2
Completed NCT02352168 - Airway Inflammation in Children With Allergic Rhinitis and Intervention N/A
Not yet recruiting NCT02233426 - Effect of Hypertonic Solutions on Allergic Rhinitis Patients N/A
Completed NCT01918956 - PURETHAL Birch RUSH Study Phase 4
Completed NCT01946035 - Alpha-Blockers in Allergic Rhinitis (MAN 01) Phase 4
Completed NCT01682070 - SUBLIVAC FIX Phleum Pratense DT/DRF Phase 2
Recruiting NCT01454492 - The Relationship Between Allergic Rhinitis and Geographic Tongue N/A
Completed NCT01438463 - PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis Phase 2