Allergic RhinitisPhase 3BALLNCT00628108

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

A Phase 3 study testing Levocetirizine 1.25 mg in people with Allergic Rhinitis and Chronic Urticaria, run by UCB Pharma at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 6 to 11 months
Conditions the study is for: Allergic Rhinitis, Chronic Urticaria
What is being tested?: Levocetirizine 1.25 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 26 sitesUnited States
Study dates: Mar 2008to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 11 months
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Show all 24Show fewer

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)

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Study site
Albany, Georgia
Study site
Austin, Texas
Study site
Bakersfield, California
Study site
Barnwell, South Carolina
Study site
Birmingham, Alabama
Study site
Bridgeton, Missouri
Study site
Crescent City, California
Study site
Dallas, Texas
Study site
El Paso, Texas
Study site
Gainesville, Georgia
Study site
Hot Springs, Arkansas
Study site
Huntington Beach, California
Study site
Jonesboro, Arkansas
Study site
Kingsport, Tennessee
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Normal, Illinois
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Orange, California
Study site
Richmond, Virginia
Study site
Roseville, California
Study site
San Antonio, Texas
Study site
Spartanburg, South Carolina
Study site
Stockton, California
Study site
Sugarland, Texas

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.

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

Conditions: Allergic Rhinitis, Chronic Urticaria
Being tested: Levocetirizine 1.25 mg, Placebo
Keywords: Xyzal, Levocetirizine, Allergy, Children, Seasonal Allergies
Medical subject headings: Rhinitis, Allergic, Chronic Urticaria, Hypersensitivity, Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levocetirizine 1.25 mgDrug
Also called Xyzal
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
PlaceboOther
Placebo oral liquid once a day for two weeks

Study groups in NCT00628108
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Other: Placebo
Levocetirizine	Experimental	Not described Receives: Drug: Levocetirizine 1.25 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Measured: Baseline, 14 days
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)
Measured: Baseline, 14 days
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)
Measured: Baseline, 14 days
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)
Measured: Baseline, 14 days
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)
Measured: Baseline, 14 days
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)
Measured: Baseline, 14 days
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)
Measured: 7 days
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)
Measured: 14 days

Secondary outcomes (5)

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Measured: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Measured: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
Measured: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Measured: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Measured: Baseline, 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Sep 2008

First posted4 Mar 2008 (estimated)
Study startMar 2008
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Allergic RhinitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00628108
Sponsor's protocol ID: A00423
Other IDs: RPCE08K2403, 2007-003458-28
Acronym: BALL
Status last verified: Feb 2015
First submitted: 22 Feb 2008
Last updated: 6 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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-Aug;31(4):290-5. doi: 10.2500/aap.2010.31.3349.
PubMed 20819318

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.
ClinicalTrials.gov ID: NCT00628108
Acronym / sponsor ID: BALL / A00423
Conditions: Allergic Rhinitis, Chronic Urticaria
Keywords: Xyzal, Levocetirizine, Allergy, Children, Seasonal Allergies
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 4 Mar 2008 (estimated)
Results: Posted 14 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo
Levocetirizine	Experimental	Drug: Levocetirizine 1.25 mg

Who may qualify

Ages: 6 to 11 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
Time frame: Baseline, 14 days
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
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
The QRS duration 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
Time frame: Baseline, 14 days
The QT interval refers to the respective time 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
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
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
The QT interval refers to the respective time interval in the Electrocardiogram (ECG)

5 secondary outcomes

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Time frame: Baseline, 14 days

Results and safety

Results posted to the registry on 14 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	23	22
Levocetirizine	46	43

Primary outcome: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)

Time frame: Baseline, 14 days. Mean (Standard Deviation). Unit: beats per minute

Measure	Placebo n = 20	Levocetirizine n = 38
Value	-7.6 (17.3)	-4.0 (16.9)

Population analysed: Safety Population; only non-missing values were analyzed

Primary outcome: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval

Time frame: Baseline, 14 days. Mean (Standard Deviation). Unit: milliseconds

Measure	Placebo n = 20	Levocetirizine n = 38
Value	28.0 (63.9)	14.9 (58.4)

Population analysed: Safety Population; only non-missing values were analyzed

Primary outcome: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval

Time frame: Baseline, 14 days. Mean (Standard Deviation). Unit: milliseconds

Measure	Placebo n = 20	Levocetirizine n = 38
Value	0.8 (11.3)	3.1 (11.3)

Population analysed: Safety Population; only non-missing values were analyzed

Primary outcome: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration

Time frame: Baseline, 14 days. Mean (Standard Deviation). Unit: milliseconds

Measure	Placebo n = 20	Levocetirizine n = 38
Value	1.4 (6.4)	0.3 (5.7)

Population analysed: Safety Population; only non-missing values were analyzed

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 24 (0%)	17 of 24 (70.8%)	Not reported
Levocetirizine	1 of 45 (2.2%)	29 of 45 (64.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20819318Hampel 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-Aug;31(4):290-5. doi: 10.2500/aap.2010.31.3349.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Allergic Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
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Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levocetirizine 1.25 mg in people with Allergic Rhinitis and Chronic Urticaria, run by UCB Pharma at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (time frame: Baseline, 14 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00628108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.