Rhinitis, Allergic, SeasonalPhase 3NCT00315523
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
A Phase 3 study testing Levocetirizine in people with Rhinitis, Allergic, Seasonal, run by UCB Pharma at 1 site in Canada.
Trial summary
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Levocetirizine
- How many people
- 403 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Oct 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol
Who cannot join
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Levocetirizine
- Keywords
- Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis
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 efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.
Secondary outcomes (1)
Reduction in other SAR symptoms at different time points; Safety .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- Double blind
- Enrolment
- 403 participants
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
- NCT00315523
- Sponsor's protocol ID
- A00415
- Status last verified
- May 2012
- First submitted
- 14 Apr 2006
- Last updated
- 16 Dec 2013
- Results posted
- No
Publications
Patel P, Patel D. Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. Ann Allergy Asthma Immunol. 2008 Sep;101(3):287-94. doi: 10.1016/S1081-1206(10)60494-2.
PubMed 18814452
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
- Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.
- ClinicalTrials.gov ID
- NCT00315523
- Acronym / sponsor ID
- A00415
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 18 Apr 2006 (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.
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol
Key exclusion criteria (2 listed)
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
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 efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.
1 secondary outcome
Reduction in other SAR symptoms at different time points; Safety .
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.
- Derived from this study: PubMed 18814452Patel P, Patel D. Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. Ann Allergy Asthma Immunol. 2008 Sep;101(3):287-94. doi: 10.1016/S1081-1206(10)60494-2.
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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
1 site 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 in people with Rhinitis, Allergic, Seasonal, run by UCB Pharma at 1 site in Canada.
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 2 inclusion and 2 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 1 site in Canada. 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 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?
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 efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.. 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 NCT00315523, 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 16 Dec 2013.