URTICARIAPhase 2NCT00199238
Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria
A Phase 2 study testing Rupatadine Fumarate in people with URTICARIA, run by J. Uriach and Company at 1 site in France.
Trial summary
The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms. 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 Fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2002to 27 Sep 2004
- Phase
- Phase 2
- 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
- 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 Day 0
- Active CIU (score ³2 labelled 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 labelled as moderate pruritus for these 3 days
- Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator
- Patient who signed the informed consent form -
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 (10 days prior to Day 0), loratadine, cetirizine, hydroxyzine, diphenhydramine, cyproheptadine, etc. (3 days prior to Day 0)
- H2-receptor antagonists: cimetidine, ranitidine and famotidine (2 days prior to Day 0)
- H1- and H2-receptor antagonists: doxepin (7 days prior to Day 0)
- Leukotriene antagonists: zafirlukast and montelukast (4 days prior to Day 0)
Show all 21Show fewer
- Corticosteroids: prednisone and methylprednisolone (7 days prior to Day 0)
- Tricyclic antidepressants: imipramin and amitriptilin (30 days prior to Day 0)
- The informed consent form must be signed prior to any washout period is set up.
- Physical urticaria due to cold, heat, and/or sun
- Cholinergic urticaria
- Patient taking any potential inhibitors of the CYP3A4 isozyme of cytochrome P450 such as ketoconazole, erythromycin and/or tricyclic antidepressants, e.g. imipramin, amitriptilin, etc.
- Urticaria due to known aetiology (e.g., medications, insects bites, food, etc)
- Patient unresponsive to antihistaminic treatment
- Patient with psychiatric disorders, vascular, hepatic, neurological, endocrine or other major systemic disease
- Pregnant or lactating female
- Patient with any heart abnormality of clinical relevance or any pathological changes of the heart rate
- Patient under any medication which could interfere with drug effect or with interpretation of efficacy parameters
- Subject handling dangerous machinery or driving as an integral part of his/her occupation
- Patient with hereditary angioedema or isolated dermographism
- Patient with disease caused by a parasite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-week Dose-finding, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety of Different Doses of Rupatadine Compared to Placebo in the Treatment of Chronic Idiopathic Urticaria
The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.
Read the detailed description
Objectives: To evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.
Methodology: A dose-finding multicentre, double-blind, randomised, placebo-controlled, parallel-group study Number of patients (planned and analysed): 248 patients. 62 patients will be allocated to each treatment group. 283 patients were randomised and analysed.
Diagnosis and criteria for inclusion: Man or woman aged between 12 and 65. 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 Day 0 . Active CIU (score ³2 labelled 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 labelled as moderate pruritus for these 3 days. Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator. Patient who signed the informed consent form.
Test product, dose, mode of administration, batch N°: Rupatadine 5,10 and 20 mg tablets; oral dose of 1 tablet/day for 4 consecutive weeks; batch 0102 (France) and batch 0203 (Hungary, Romania and Argentina). Expiry date: 12/2003 (France) and 10/2004 (Hungary, Romania and Argentina).
Duration of treatment: Oral administration of test formulation (5, 10, 20 mg) or placebo daily, for 4 consecutive weeks.
Reference therapy: Placebo tablets, 1 tablet/day for 4 consecutive weeks. Criteria for evaluation (efficacy): 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-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 and the interference with sleep and daily activities due to urticaria symptoms Criteria for evaluation (safety): AEs, laboratory tests and vital signs
- Conditions
- URTICARIA
- Being tested
- Rupatadine Fumarate
- Keywords
- ANTIHISTAMINE, RUPATADINE, WHEAL, FLARE, DERMATOLOGY
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rupatadine FumarateDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Once daily/ 28 days Receives: Drug: Rupatadine Fumarate |
| rupatadine 5mg | Experimental | Once daily/ 28 days Receives: Drug: Rupatadine Fumarate |
| rupatadine 10 mg | Experimental | Once daily/ 28 days Receives: Drug: Rupatadine Fumarate |
| rupatadine 20 mg | Experimental | Once daily/ 28 days Receives: Drug: Rupatadine Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus
change in mean pruritus score (MPS) over the 4-week treatment period.
Measured: 4 weeks
Secondary outcomes (3)
Wheals
change in mean number of wheals score (MNW) over the 4-week treatment period.
Measured: 4 weeks
change in mean total symptoms score (MTSS) over the 4-week treatment period.
Measured: 4 weeks
overall impression
overall impression for efficacy was done by the investigator and by the patient
Measured: 4 weeks
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 start28 Oct 2002
- Primary completion25 Nov 2003
- Study completion27 Sep 2004
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- EVA Arnaiz, PhD, Study director, J. Uriach y Compañía
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199238
- Sponsor's protocol ID
- 2002/47
- Status last verified
- Feb 2022
- First submitted
- 12 Sep 2005
- Last updated
- 18 Feb 2022
- Results posted
- No
Publications
Dubertret L, Zalupca L, Cristodoulo T, Benea V, Medina I, Fantin S, Lahfa M, Perez I, Izquierdo I, Arnaiz E. Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study. Eur J Dermatol. 2007 May-Jun;17(3):223-8. doi: 10.1684/ejd.2007.0153. Epub 2007 May 4.
PubMed 17478385
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Dose-finding, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety of Different Doses of Rupatadine Compared to Placebo in the Treatment of Chronic Idiopathic Urticaria
- ClinicalTrials.gov ID
- NCT00199238
- Acronym / sponsor ID
- 2002/47
- Conditions
- URTICARIA
- Keywords
- ANTIHISTAMINE, RUPATADINE, WHEAL, FLARE, DERMATOLOGY
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 248 participants (actual)
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2002 (actual)
- Primary completion
- 25 Nov 2003 (actual)
- Study completion
- 27 Sep 2004 (actual)
- 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.
The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.
Detailed description
Objectives: To evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.
Methodology: A dose-finding multicentre, double-blind, randomised, placebo-controlled, parallel-group study Number of patients (planned and analysed): 248 patients. 62 patients will be allocated to each treatment group. 283 patients were randomised and analysed.
Diagnosis and criteria for inclusion: Man or woman aged between 12 and 65. 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 Day 0 . Active CIU (score ³2 labelled 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 labelled as moderate pruritus for these 3 days. Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator. Patient who signed the informed consent form.
Test product, dose, mode of administration, batch N°: Rupatadine 5,10 and 20 mg tablets; oral dose of 1 tablet/day for 4 consecutive weeks; batch 0102 (France) and batch 0203 (Hungary, Romania and Argentina). Expiry date: 12/2003 (France) and 10/2004 (Hungary, Romania and Argentina).
Duration of treatment: Oral administration of test formulation (5, 10, 20 mg) or placebo daily, for 4 consecutive weeks.
Reference therapy: Placebo tablets, 1 tablet/day for 4 consecutive weeks. Criteria for evaluation (efficacy): 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-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 and the interference with sleep and daily activities due to urticaria symptoms Criteria for evaluation (safety): AEs, laboratory tests and vital signs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Rupatadine FumarateOnce daily/ 28 days |
| rupatadine 5mg | Experimental | Drug: Rupatadine FumarateOnce daily/ 28 days |
| rupatadine 10 mg | Experimental | Drug: Rupatadine FumarateOnce daily/ 28 days |
| rupatadine 20 mg | Experimental | Drug: Rupatadine FumarateOnce daily/ 28 days |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman aged between 12 and 65
- 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 Day 0
- Active CIU (score ³2 labelled 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 labelled as moderate pruritus for these 3 days
- Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator
- Patient who signed the informed consent form -
Key exclusion criteria (21 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.
- Physical urticaria due to cold, heat, and/or sun
- 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 FumarateAlso: Placebo | Drug | Placebo, rupatadine 10 mg, rupatadine 20 mg, rupatadine 5mg |
Primary outcome
Pruritus
Time frame: 4 weeks
change in mean pruritus score (MPS) over the 4-week treatment period.
3 secondary outcomes
Wheals
Time frame: 4 weeks
change in mean total symptoms score (MTSS) over the 4-week treatment period.
Time frame: 4 weeks
overall impression
Time frame: 4 weeks
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 18 Feb 2022.
- Results publication: PubMed 17478385Dubertret L, Zalupca L, Cristodoulo T, Benea V, Medina I, Fantin S, Lahfa M, Perez I, Izquierdo I, Arnaiz E. Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study. Eur J Dermatol. 2007 May-Jun;17(3):223-8. doi: 10.1684/ejd.2007.0153. Epub 2007 May 4.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rupatadine Fumarate in people with URTICARIA, run by J. Uriach and Company at 1 site in France.
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 21 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 18 Feb 2022. 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 France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pruritus (time frame: 4 weeks). 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 NCT00199238, 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 18 Feb 2022.