RhinitisPhase 4NCT00521131
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
A Phase 4 study testing Levocetirizine dihydrochloride in people with Rhinitis and Allergic, run by UCB Pharma.
Trial summary
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Levocetirizine dihydrochloride
- How many people
- 453 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to May 2003
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- male or female ≥ 12 years
- suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
- positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
- the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5
Who cannot join
- seasonal allergic rhinitis likely to change significantly the symptoms of the subject
- an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
- asthma requiring corticosteroid treatment
- atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
- associated ENT disease
About this study
Official title: Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
- Being tested
- Levocetirizine dihydrochloride
- Keywords
- Levocetirizine dihydrochloride, Xyzal tablets
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocetirizine dihydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of comfortable days, as assessed by the subject
Measured: 30 days
Secondary outcomes (1)
Sum of 4 and 5 rhinitis symptoms and safety
Measured: Week 1 and over 30 days
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 startSep 2002
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 453 participants (actual)
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
- NCT00521131
- Sponsor's protocol ID
- A00333
- Status last verified
- Sep 2009
- First submitted
- 24 Aug 2007
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- 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
- Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
- ClinicalTrials.gov ID
- NCT00521131
- Acronym / sponsor ID
- A00333
- Keywords
- Levocetirizine dihydrochloride, Xyzal tablets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (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.
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- male or female ≥ 12 years
- suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
- positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
- the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5
Key exclusion criteria (5 listed)
- seasonal allergic rhinitis likely to change significantly the symptoms of the subject
- an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
- asthma requiring corticosteroid treatment
- atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
- associated ENT disease
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 dihydrochloride | Drug | – |
Primary outcome
Number of comfortable days, as assessed by the subject
Time frame: 30 days
1 secondary outcome
Sum of 4 and 5 rhinitis symptoms and safety
Time frame: Week 1 and over 30 days
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocetirizine dihydrochloride in people with Rhinitis and Allergic, run by UCB Pharma.
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 4 inclusion and 5 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.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of comfortable days, as assessed by the subject (time frame: 30 days). 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.