Chronic Idiopathic UrticariaPhase 4NCT00264303
CUTE (Chronic Urticaria Treatment Evaluation)
A Phase 4 study testing Levocetirizine and Desloratadine in people with Chronic Idiopathic Urticaria, run by UCB Pharma at 80 sites in 9 countries.
Trial summary
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- Levocetirizine and Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 886 participants
- Where
- 80 sitesin 9 countries
- Study dates
- Dec 2005to Jan 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause
- At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.
Who cannot join
- Any condition that would interfere with the evaluation of the therapeutic response.
Trial locations and contacts
80 sites in 9 countries.
80 sites in 9 countries
France17 sites
Study site
Bernay
Study site
Besançon
Study site
Hyères
Study site
Les Milles
Study site
Marseille
Study site
Montpellier
Study site
Nancy
Study site
Nantes
Study site
Nice
Study site
Nîmes
Study site
Paris
Study site
Poitiers
Study site
Quimper
Study site
Saint-Mandé
Study site
Troyes
Study site
Valence
Study site
Villejuif
Germany14 sites
Study site
Augsburg
Study site
Berlin
Study site
Cologne
Study site
Dresden
Study site
Düsseldorf
Study site
Erlangen
Study site
Göttingen
Study site
Hamburg
Study site
Hanover
Study site
Leipzig
Study site
Mahlow
Study site
Mainz
Study site
München
Study site
Viersen
Italy11 sites
Study site
Caserta
Study site
Catania
Study site
Cesena
Study site
Genova
Study site
Modena
Study site
Palermo
Study site
Pavia
Study site
Roma
Study site
Siena
Study site
Udine
Study site
Verona
Spain11 sites
Study site
A Coruña
Study site
Albacete
Study site
Barcelona
Study site
Granada
Study site
Madrid
Study site
Málaga
Study site
Murcia (El Palmar)
Study site
Oviedo
Study site
Santiago de Compostela
Study site
Seville
Study site
Valencia
Malaysia7 sites
Study site
Johor Bharu
Study site
Kelantan
Study site
Kuala Lumpur
Study site
Negeri Sembilan
Study site
Perak
Study site
Pulau Pinang
Study site
Sarawak
United Kingdom7 sites
Study site
Amersham
Study site
Cardiff
Study site
Irvine
Study site
Leicester
Study site
London
Study site
Nuneaton
Study site
Salford
Belgium6 sites
Study site
Bruges
Study site
Brussels
Study site
Liège
Study site
Merksem
Study site
Sint-Niklaas
Study site
Woluwe-St-Lamb
Romania4 sites
Study site
Brasov
Study site
Bucharest
Study site
Dolj
Study site
Sibiu
South Africa3 sites
Study site
Cape Town
Study site
Durban
Study site
Lenasia
About this study
Official title: A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- Levocetirizine, Desloratadine
- Keywords
- Chronic Idiopathic Urticaria, CUTE Levocetirizine Xyzal®
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
5mg oral capsules, once daily, 4 week duration
DesloratadineDrug
5mg oral capsules, once daily, 4 week duration
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine | Experimental | Levocetirizine, once daily, 4 week duration Receives: Drug: Levocetirizine |
| Desloratadine | Active comparator | Desloratadine, once daily, 4 week duration Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pruritus Severity Score Over the First Week of Treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.
Measured: over the first week of treatment
Secondary outcomes (5)
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment.
Measured: over the first week of treatment
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.
Measured: over the four weeks of treatment
Mean Pruritus Severity Score Over the Four Weeks of Treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.
Measured: over the four weeks of treatment
Mean Score for Pruritus Duration Over the First Week of Treatment
The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.
Measured: over the first week of treatment
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.
Measured: over the four weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2007
- Study completionJan 2007
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.
- Other trials for Chronic Idiopathic UrticariaStudies 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
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264303
- Sponsor's protocol ID
- A00394
- Other IDs
- EudraCT 2005-000358-65, CUTE
- Status last verified
- Jun 2011
- First submitted
- 8 Dec 2005
- Last updated
- 31 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)
- ClinicalTrials.gov ID
- NCT00264303
- Acronym / sponsor ID
- A00394
- Conditions
- Chronic Idiopathic Urticaria
- Keywords
- Chronic Idiopathic Urticaria, CUTE Levocetirizine Xyzal®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Posted 9 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine | Experimental | Drug: LevocetirizineLevocetirizine, once daily, 4 week duration |
| Desloratadine | Active comparator | Drug: DesloratadineDesloratadine, once daily, 4 week duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause
- At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.
Key exclusion criteria (1 listed)
- Any condition that would interfere with the evaluation of the therapeutic response.
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 |
|---|---|---|
| Levocetirizine5mg oral capsules, once daily, 4 week duration | Drug | Levocetirizine |
| Desloratadine5mg oral capsules, once daily, 4 week duration | Drug | Desloratadine |
Primary outcome
Mean Pruritus Severity Score Over the First Week of Treatment
Time frame: over the first week of treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.
5 secondary outcomes
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
Time frame: over the first week of treatment
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
Time frame: over the four weeks of treatment
Mean Pruritus Severity Score Over the Four Weeks of Treatment
Time frame: over the four weeks of treatment
Mean Score for Pruritus Duration Over the First Week of Treatment
Time frame: over the first week of treatment
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
Time frame: over the four weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Chronic Spontaneous Urticaria
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A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
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Chronic Spontaneous Urticaria
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A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
Chronic Spontaneous Urticaria (CSU)
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)
80 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocetirizine and Desloratadine in people with Chronic Idiopathic Urticaria, run by UCB Pharma at 80 sites in 9 countries.
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 1 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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in France, Germany, Italy, Spain, Malaysia and 4 more countries. 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 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?
Yes. Results are posted in the registry (first posted 9 Jul 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?
Mean Pruritus Severity Score Over the First Week of Treatment (time frame: over the first week of treatment). 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 31 Aug 2011.