Chronic Idiopathic UrticariaPhase 4NCT00346606
The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
A Phase 4 study testing Denosin® and Xyzal® in people with Chronic Idiopathic Urticaria and Urticaria, run by Lotus Pharmaceutical at 1 site in Taiwan.
Trial summary
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks. Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Idiopathic Urticaria, Urticaria
- What is being tested?
- Denosin® and Xyzal®
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to not given
- 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
- The subject or deputy has read or been informed and signed the Informed Consent Agreement and the subject will be willing and able to participate in the study.
- The subject ≥ 12 years old.
- The subject with documented signs and symptoms of CIU for 6 weeks or more.
- The subject has to have a CIU flare for 3 weeks or more before screening, with urticarial lesions visible 3 days or more per week.
- The overall severities of CIU have to be at least mild to moderate at screening and baseline, subjects have to have at least mild to moderate pruritus, hives have to be apparent at screening, and subjects have intention to treatment.
Who cannot join
- The subject has received any histamine, corticosteroids, ketotifene, systemic antibiotics, nedocromil, sodium cromoglycate or thyroxin drug within 7 days preceding randomization.
- The subject has received any other investigational drug within one month preceding randomization.
- The subject has previous non-response to antihistamines.
- The subject has previous allergy or allergies of desloratadine or levocetirizine.
- The subject need for long-term corticosteroids treatment (including inhaled, oral and topical dosage).
- The subject has autoimmune diseases.
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- The subject's urticaria is physical urticaria, cholinergic urticaria or angioedema.
- The subject is in the situation of pregnancy or breastfeeding.
- The subject has liver dysfunction (AST ≧ 3 times normal range; ALT ≧ 3 times normal range ) or renal dysfunction (Creatinine ≧ 3.0mg/dl ).
- The subject is unable to keep an accurate diary of disease symptoms.
- The subject has significant concomitant illness, which, in the opinion of the investigator, will interfere with the evaluation of the study medications.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Dermatology National Taiwan University Hospital
Taipei
Jia-Yu Chu, +886-2-23123456 ext. 5734
Jia-Yu Chu
About this study
Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Compare the Efficacy and Safety of Desloratadine 5mg (Denosin®) With Levocetirizine 5mg (Xyzal®) in the Treatment of Chronic Idiopathic Urticaria Patients
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.
Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Primary end point: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.
Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.
Read the detailed description
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.
Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Primary endpoint: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.
Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.
Primary endpoint:
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
Secondary Endpoints- To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.
To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).
Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.
Therapeutic response will be evaluated at visit 3~5.
Safety will be evaluated including vital signs are recorded at all visits, whereas sleep latency using Epworth Sleepiness Scale (ESS) questionnaire and Visual analogue Scale (VAS) are scored at visit 2~5. Stanford Sleepiness Scale (SSS) are scored according to the instructions of diary cards at all visits. All adverse events are recorded and graded for severity at visit 2~5.
- Conditions
- Chronic Idiopathic Urticaria, Urticaria
- Being tested
- Denosin® and Xyzal®
- Keywords
- Chronic Idiopathic Urticaria, Desloratadine, Denosin, Levocetirizine
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosin® and Xyzal®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
Secondary outcomes (7)
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.
To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).
Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Lotus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jia-Yu Chu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346606
- Sponsor's protocol ID
- 187CL1
- Status last verified
- May 2006
- First submitted
- 29 Jun 2006
- Last updated
- 30 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Compare the Efficacy and Safety of Desloratadine 5mg (Denosin®) With Levocetirizine 5mg (Xyzal®) in the Treatment of Chronic Idiopathic Urticaria Patients
- ClinicalTrials.gov ID
- NCT00346606
- Acronym / sponsor ID
- 187CL1
- Conditions
- Chronic Idiopathic Urticaria, Urticaria
- Keywords
- Chronic Idiopathic Urticaria, Desloratadine, Denosin, Levocetirizine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Lotus PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 30 Jun 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.
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.
Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Primary end point: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.
Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.
Detailed description
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.
Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Primary endpoint: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.
Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.
Primary endpoint:
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
Secondary Endpoints- To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.
To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).
Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.
Therapeutic response will be evaluated at visit 3~5.
Safety will be evaluated including vital signs are recorded at all visits, whereas sleep latency using Epworth Sleepiness Scale (ESS) questionnaire and Visual analogue Scale (VAS) are scored at visit 2~5. Stanford Sleepiness Scale (SSS) are scored according to the instructions of diary cards at all visits. All adverse events are recorded and graded for severity at visit 2~5.
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 (5 listed)
- The subject or deputy has read or been informed and signed the Informed Consent Agreement and the subject will be willing and able to participate in the study.
- The subject ≥ 12 years old.
- The subject with documented signs and symptoms of CIU for 6 weeks or more.
- The subject has to have a CIU flare for 3 weeks or more before screening, with urticarial lesions visible 3 days or more per week.
- The overall severities of CIU have to be at least mild to moderate at screening and baseline, subjects have to have at least mild to moderate pruritus, hives have to be apparent at screening, and subjects have intention to treatment.
Key exclusion criteria (11 listed)
- The subject has received any histamine, corticosteroids, ketotifene, systemic antibiotics, nedocromil, sodium cromoglycate or thyroxin drug within 7 days preceding randomization.
- The subject has received any other investigational drug within one month preceding randomization.
- The subject has previous non-response to antihistamines.
- The subject has previous allergy or allergies of desloratadine or levocetirizine.
- The subject need for long-term corticosteroids treatment (including inhaled, oral and topical dosage).
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 |
|---|---|---|
| Denosin® and Xyzal® | Drug | – |
Primary outcome
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
7 secondary outcomes
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.
To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).
Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2006.
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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.
Jia-Yu Chu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosin® and Xyzal® in people with Chronic Idiopathic Urticaria and Urticaria, run by Lotus Pharmaceutical at 1 site in Taiwan.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Jun 2006. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leanne Chou (+886-2-27738816 ext. 313, Leanne@lotuspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks 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 30 Jun 2006.