AllergyPhase 1NCT00521170
Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.
A Phase 1 study testing Levocetirizine in people with Allergy, run by UCB Pharma at 2 sites in France.
Trial summary
Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergy
- What is being tested?
- Levocetirizine
- How many people
- Not given
- Where
- 2 sitesFrance
- Study dates
- Nov 2004to Jan 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Adult
Who may be able to join
- Male and female allergic volunteers: Diagnosed allergy based on medical history and on positivity to skin tests to at least one of the standardized allergen including grass pollens, tree pollens, house dust mites, cat and dog dander and with a positive RAST for the specific selected allergen ≥ class 2
Who cannot join
- Pregnancy or lactating females, or females with childbearing potential without reliable contraception
- History or presence of any chronic or acute illness or disorder capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the trial medication
- Heavy caffeine drinker (> 5 cups of coffee, tea, cola, etc … per day)
- Any drug treatment, including prescribed or non-prescription medicines (except hormonal contraceptives or post-menopausal hormonal replacement therapy for females and occasional use of paracetamol not exceeding 2 g/day with a maximum dose of 10 g per 14 days), taken from 14 days before study drug administration; the wash-out period after intake of systemic corticosteroids is at least 4 weeks
- Known allergy/intolerance to the study drug or any medicine chemically related to study drug or its excipients (lactose, cellulose...)
- Participation in another clinical trial, blood donation or significant blood loss (> 450 mL) less than 12 weeks before the study drug administration
Show all 9Show fewer
- Skin irritant or 48 hours UV exposure before each visit
- Immunotherapy received during the current year
- Any clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable for the trial
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized, Monocenter, Double Blind, Placebo-controlled, Single Oral Dose, Three-way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers.
Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.
- Conditions
- Allergy
- Being tested
- Levocetirizine
- Keywords
- Levocetirizine, Wheal and flare, Allergic
- Medical subject headings
- Hypersensitivity, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the activity of levocetirizine and desloratadine on allergen-induced wheal and flare reaction. Response to allergen administered by skin prick test (SPT) measured by the wheal and flare surface areas
Measured: 15 minutes
Secondary outcomes (1)
Compare the AUC from pre-dose to 24 hours post-dose between levocetirizine and placebo and between desloratadine and placebo obtained for wheal and for flare areas. Compare the AUC from pre-dose to 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startNov 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521170
- Sponsor's protocol ID
- A00373
- Other IDs
- Eudract Number: 2004-001089-41
- Status last verified
- Sep 2009
- First submitted
- 24 Aug 2007
- Last updated
- 16 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Monocenter, Double Blind, Placebo-controlled, Single Oral Dose, Three-way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers.
- ClinicalTrials.gov ID
- NCT00521170
- Acronym / sponsor ID
- A00373
- Conditions
- Allergy
- Keywords
- Levocetirizine, Wheal and flare, Allergic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female allergic volunteers: Diagnosed allergy based on medical history and on positivity to skin tests to at least one of the standardized allergen including grass pollens, tree pollens, house dust mites, cat and dog dander and with a positive RAST for the specific selected allergen ≥ class 2
Key exclusion criteria (9 listed)
- Pregnancy or lactating females, or females with childbearing potential without reliable contraception
- History or presence of any chronic or acute illness or disorder capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the trial medication
- Heavy caffeine drinker (> 5 cups of coffee, tea, cola, etc … per day)
- Any drug treatment, including prescribed or non-prescription medicines (except hormonal contraceptives or post-menopausal hormonal replacement therapy for females and occasional use of paracetamol not exceeding 2 g/day with a maximum dose of 10 g per 14 days), taken from 14 days before study drug administration; the wash-out period after intake of systemic corticosteroids is at least 4 weeks
- Known allergy/intolerance to the study drug or any medicine chemically related to study drug or its excipients (lactose, cellulose...)
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 | Drug | – |
Primary outcome
Compare the activity of levocetirizine and desloratadine on allergen-induced wheal and flare reaction. Response to allergen administered by skin prick test (SPT) measured by the wheal and flare surface areas
Time frame: 15 minutes
1 secondary outcome
Compare the AUC from pre-dose to 24 hours post-dose between levocetirizine and placebo and between desloratadine and placebo obtained for wheal and for flare areas. Compare the AUC from pre-dose to 12 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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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
UCB Pharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levocetirizine in people with Allergy, run by UCB Pharma at 2 sites in France.
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 1 inclusion and 9 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the activity of levocetirizine and desloratadine on allergen-induced wheal and flare reaction. Response to allergen administered by skin prick test (SPT) measured by the wheal and flare surface areas (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2013.