UrticariaPhase 3NCT00199251
Efficacy and Safety of Rupatadine 10 and 20 Mg in Chronic Idiopathic Urticaria
A Phase 3 study testing RUPATADINE in people with Urticaria, run by J. Uriach and Company.
Trial summary
· To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Urticaria
- What is being tested?
- RUPATADINE
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jun 2005
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Man or woman aged between 12 and 65
- Active CIU (score ³2 labeled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU ³6 labeled as moderate pruritus for these 3 days
- Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Screening Visit.
- 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Bazzet's correction must be normal (not prolonged). The values considered to be normal are < 430 msec for males and < 450 msec for females.
- Patient who signed the informed consent form. In case the patient to be underage (from 12 to 18, -and 21 for Argentina-) the written informed consent of one of his/her parents or legal guardian is required.
- Women of childbearing potential should have a negative pregnancy test at the time of inclusion. In addition, they must use an effective contraceptive method (i.e. oral, IUD, condom, etc). The commitment of the patient to use these measures while participating in this clinical trial will be considered as sufficient.
Who cannot join
- CIU associated to some underlying disease (Hodgkin's disease/vasculitis/lupus erythematous/hepatitis)
- Patient under any systemic or topical medication for CIU and/or an inferior wash-out period as stated as follows:
- H1-receptor antagonists: fexofenadine (5 days prior to Day 0), loratadine, desloratadine, cetirizine, hydroxyzine, diphenhydramine, cyproheptadine, etc. (3 days prior to Day 0)
- H2-receptor antagonists: cimetidine, ranitidine, famotidine, etc (2 days prior to Day 0)
- H1- and H2-receptor antagonists: doxepin (7 days prior to Day 0)
- Leukotriene antagonists: zafirlukast, montelukast, etc (4 days prior to Day 0)
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- Corticosteroids: prednisone, methylprednisolone, etc ( 28 days prior to Day 0)
- Tricyclic antidepressants: imipramin, amitriptilin, etc (30 days prior to Day 0)
- The informed consent form must be signed prior to any washout period is set up.
- Patients with analytical values twice as high than the upper limit of normality in the following parameters: ALP, ALT, AST, GGT and creatinine, and 1,5 times higher for than the upper limit of normality for the CK. Any other laboratory relevant finding should be assessed by the investigator before patient inclusion.
- Cholinergic urticaria.
- Patient taking medication that is known to interact with CYP3A4 isozyme of cytochrome P450 such as amiodarone, carbamazepine, cyclosporin, terfenadine, glucocorticoids, phenytoin, rifampicin, macrolides (e.g. erythromycin,clarytomicine, etc) and antifungal (e.g. ketoconazole, miconazole, fluconazole, etc) as well as grapefruit juice.
- Urticaria due to known etiology (e.g. medications, insects bites, food, cold/heat, sun, etc)
- Patient that after review of his medical history, is considered by the investigator as unresponsive to antihistaminic treatment
- Pregnant or lactating female
- Patients who are currently participating in or have participated in another clinical trial within the last three months
- Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse
- Patient taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine.
- Patient under any other treatment that could lead to symptomatic relief of the urticaria symptoms, for example: creams, lotions, ointments, homeopathy, etc… with or without recognized active ingredient.
- (../.)
About this study
Official title: A 6-Week Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Rupatadine 10 and 20 Mg in the Treatment of Chronic Idiopathic Urticaria (CIU): a Phase III Clinical Trial
- To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
Read the detailed description
STUDY PHASE III OBJECTIVES · To evaluate the efficacy and safety of rupatadine 10 mg and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
DESIGN · A multicentre, double blind, randomised, placebo controlled, parallel-group study in 300 patients (100 patients each treatment) group.
INDICATION · Chronic Idiopathic Urticaria (CIU) ASSESSMENT Primary efficacy measure of each treatment will compare the frequency and severity of symptoms of CIU as measured by the patient in terms of change in mean pruritus score (MPS) over the 4-week treatment period.Secondary efficacy measures include change from baseline over the 4 and 6-week treatment period in the mean number of wheals (MNW) score; mean total symptoms score (MTSS), calculated as the sum of the MPS (Mean pruritus symptoms) and the MNW (Mean number of wheals) scores, severity of symptoms of CIU as measured by the patient in terms of change in mean pruritus score (MPS) over the 6-week treatment period, Visual Analogic Scale (VAS) and Quality of life (QoL) which will be assessed by the "Dermatology Life Quality Index" (DLQI).Safety: ECGs baseline and final visit; clinical laboratory controls, physical examination, incidence of adverse events (AE).
STUDY POPULATION 300 patients between 12-65 years of age, with CIU
- Conditions
- Urticaria
- Being tested
- RUPATADINE
- Keywords
- URTICARIA, WHEALS, FLARE, ANTIHISTAMINE, ANTIHISTAMINE
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUPATADINEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
· To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
Secondary outcomes (4)
· To evaluate the efficacy and safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over six-week treatment period in comparison with placebo.
· To evaluate the safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
· To assess the patient discomfort by using a VAS.
· To assess the patient QoL by a specific questionnaire, the DLQI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- EVA ARNAIZ, PhD, Study director, J. Uriach y Compañía
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199251
- Sponsor's protocol ID
- IC010RUP304
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 23 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Rupatadine 10 and 20 Mg in the Treatment of Chronic Idiopathic Urticaria (CIU): a Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT00199251
- Acronym / sponsor ID
- IC010RUP304
- Conditions
- Urticaria
- Keywords
- URTICARIA, WHEALS, FLARE, ANTIHISTAMINE, ANTIHISTAMINE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jun 2005
- First posted
- 20 Sep 2005 (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 evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
Detailed description
STUDY PHASE III OBJECTIVES · To evaluate the efficacy and safety of rupatadine 10 mg and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
DESIGN · A multicentre, double blind, randomised, placebo controlled, parallel-group study in 300 patients (100 patients each treatment) group.
INDICATION · Chronic Idiopathic Urticaria (CIU) ASSESSMENT Primary efficacy measure of each treatment will compare the frequency and severity of symptoms of CIU as measured by the patient in terms of change in mean pruritus score (MPS) over the 4-week treatment period.Secondary efficacy measures include change from baseline over the 4 and 6-week treatment period in the mean number of wheals (MNW) score; mean total symptoms score (MTSS), calculated as the sum of the MPS (Mean pruritus symptoms) and the MNW (Mean number of wheals) scores, severity of symptoms of CIU as measured by the patient in terms of change in mean pruritus score (MPS) over the 6-week treatment period, Visual Analogic Scale (VAS) and Quality of life (QoL) which will be assessed by the "Dermatology Life Quality Index" (DLQI).Safety: ECGs baseline and final visit; clinical laboratory controls, physical examination, incidence of adverse events (AE).
STUDY POPULATION 300 patients between 12-65 years of age, with CIU
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman aged between 12 and 65
- Active CIU (score ³2 labeled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU ³6 labeled as moderate pruritus for these 3 days
- Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Screening Visit.
- 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Bazzet's correction must be normal (not prolonged). The values considered to be normal are < 430 msec for males and < 450 msec for females.
- Patient who signed the informed consent form. In case the patient to be underage (from 12 to 18, -and 21 for Argentina-) the written informed consent of one of his/her parents or legal guardian is required.
Key exclusion criteria (20 listed)
- CIU associated to some underlying disease (Hodgkin's disease/vasculitis/lupus erythematous/hepatitis)
- Patient under any systemic or topical medication for CIU and/or an inferior wash-out period as stated as follows:
- The informed consent form must be signed prior to any washout period is set up.
- Patients with analytical values twice as high than the upper limit of normality in the following parameters: ALP, ALT, AST, GGT and creatinine, and 1,5 times higher for than the upper limit of normality for the CK. Any other laboratory relevant finding should be assessed by the investigator before patient inclusion.
- Cholinergic urticaria.
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 |
|---|---|---|
| RUPATADINE | Drug | – |
Primary outcome
· To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
4 secondary outcomes
· To evaluate the efficacy and safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over six-week treatment period in comparison with placebo.
· To evaluate the safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
· To assess the patient discomfort by using a VAS.
· To assess the patient QoL by a specific questionnaire, the DLQI.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2005.
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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.
EVA ARNAIZ, PhD study director
J. Uriach y Compañía
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RUPATADINE in people with Urticaria, run by J. Uriach and Company.
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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 Dec 2005. 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 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 was stopped early. Results are not available in the source record.
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?
· To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.. 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 23 Dec 2005.