Efficacy and Safety of Rupatadine 10 and 20 Mg in Chronic Idiopathic Urticaria

NCT00199251 | Terminated Phase 3

• 1 other identifier: IC010RUP304
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

· 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.

Conditions

Urticaria

Keywords

URTICARIA, WHEALS, FLARE, ANTIHISTAMINE, ANTIHISTAMINE

Outcome Measures

Primary Outcomes (1)

• · 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 Outcomes (4)

• · 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.

Interventions

RUPATADINE DRUG

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Screening Visit.
• lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Bazzet's correction must be normal (not prolonged). The values considered to be normal are \< 430 msec for males and \< 450 msec for females.
• 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.

You may not qualify if:

• 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 (5 days prior to Day 0), loratadine, desloratadine, cetirizine, hydroxyzine, diphenhydramine, cyproheptadine, etc. (3 days prior to Day 0)
• H2-receptor antagonists: cimetidine, ranitidine, famotidine, etc (2 days prior to Day 0)
• H1- and H2-receptor antagonists: doxepin (7 days prior to Day 0)
• Leukotriene antagonists: zafirlukast, montelukast, etc (4 days prior to Day 0)
• 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.
• Cholinergic urticaria.
• 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, etc)
• 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

Sponsors & Collaborators

• J. Uriach and Company: lead

MeSH Terms

Conditions

Urticaria

Interventions

rupatadine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• EVA ARNAIZ, PhD

  J. Uriach y Compañía

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2004
• Study Completion: June 1, 2005
• Last Updated: December 23, 2005

Record last verified: 2005-09