Status:
TERMINATED
Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria
Lead Sponsor:
J. Uriach and Company
Conditions:
URTICARIA
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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, ...
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...
Eligibility Criteria
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 -
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
October 28 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2004
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00199238
Start Date
October 28 2002
End Date
September 27 2004
Last Update
February 18 2022
Active Locations (1)
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1
Hospital Saint Louis
Paris, France, 75475