Chronic Idiopathic Urticaria MedDRA version: 7 Level: 0 Classification code 10021247
Conditions
Interventions
Trade Name: Rupafin 10 mg comprimidos
Product Name: Rupatadine
Product Code: UR-12592
Pharmaceutical Form: Tablet
INN or Proposed INN: Rupatadine
CAS Number: 158876-82-5
Current Sponsor code: UR-12592
Sponsors
J. Uriach y Compañía, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Man or woman aged between 12 and 65 Active CIU (score equal or higher than 2 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 equal or higher than 6 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 Patient who signed the informed consent form. Women of childbearing potential should have a negative pregnancy test. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: CIU associated to some underlying disease. Patient under any systemic or topical medication for CIU and/or an inferior wash-out period as stated in the protocol. 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. Cholinergic urticaria. Patient taking medication that is known to interact with CYP3A4 isozyme of cytochrome P450. Urticaria due to known etiology. Patient unresponder to antihistaminic treatment Start an immunotherapy schedule or changes in immunotherapy schedule 6 months previously to V0. Known hypersensitivity to the study drugs (or compounds structurally related to) and to any other component of the study drugs. Kidney or hepatic failure. Pregnant or lactating female Patient with hereditary angioedema or isolated dermographism Patient with any parasitic infestations enable to cause any urticaria like symptoms-signs. Patient taking drugs strongly associated with torsade de pointes. Patient under any other treatment that could lead to symptomatic relief of the urticaria symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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. ;Primary end point(s): The primary end point will be based on the daily subjective assessment of the severity of each symptom of CIU, as recorded by patients in their diaries. Change in mean pruritus score (MPS) over the 4-week treatment period. | — |
Countries
Spain
Outcome results
None listed