Efficacy and Safety of Rupatadine 10 and 20 Mg in Chronic Idiopathic Urticaria
Information source: J. Uriach and Company
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urticaria
Intervention: RUPATADINE (Drug)
Phase: Phase 3
Sponsored by: J. Uriach and Company
Official(s) and/or principal investigator(s):
EVA ARNAIZ, PhD, Study Director, Affiliation: J. Uriach y CompaÃ±Ãa
· 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.
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Â· 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.
Â· 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.
Â· 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.
Â· To assess the patient discomfort by using a VAS.
Â· To assess the patient QoL by a specific questionnaire, the DLQI.
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
DESIGN · A multicentre, double blind, randomised, placebo controlled, parallel–group study in
300 patients (100 patients each treatment) group.
INDICATION Â· 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 âDermatology Life Quality Indexâ
(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
Minimum age: 12 Years.
Maximum age: 65 Years.
Man or woman aged between 12 and 65
Active CIU (score Â³2 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 Â³6 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
12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug
effect or disease, QTc interval values (msec) after Bazzetâs correction must be normal (not
prolonged). The values considered to be normal are < 430 msec for males and < 450 msec for
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.
CIU associated to some underlying disease (Hodgkinâs disease/vasculitis/lupus
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
H2-receptor antagonists: cimetidine, ranitidine, famotidine, etc (2 days prior to Day
H1- and H2-receptor antagonists: doxepin (7 days prior to Day 0)
Leukotriene antagonists: zafirlukast, montelukast, etc (4 days prior to Day
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.
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,
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
Patient taking drugs strongly associated with torsade de pointes such as disopyramide,
procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or
Patient under any other treatment that could lead to symptomatic relief of the urticaria
symptoms, for example: creams, lotions, ointments, homeopathy, etcâ¦ with or without
recognized active ingredient.
Locations and Contacts
Starting date: April 2004
Ending date: June 2005
Last updated: December 22, 2005