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.

J. Uriach y Compañía, S.A.0 个研究点目标入组 300 人开始时间: 2004年9月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

J. Uriach y Compañía, S.A.