Efficacy of Rupatadine 5, 10 and 20 Mg in Chronic Idiopathic Urticaria - Full Text View

Sponsor:	J. Uriach and Company
Information provided by:	J. Uriach and Company
ClinicalTrials.gov Identifier:	NCT00199238

Purpose

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, and 20 mg) compared with placebo for relief of CIU symptoms.

Condition	Intervention	Phase
Urticaria	Drug: RUPATADINE (ANTI-HISTAMINE)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 4-Week Dose-Finding, Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Different Doses of Rupatadine Compared to Placebo in the Treatment of Chronic Idiopathic Urticaria

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines Hives

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Rupatadine

U.S. FDA Resources

Further study details as provided by J. Uriach and Company:

Primary Outcome Measures:

· To assess the clinical efficacy of rupatadine and determine the most effective and well tolerated dose in the treatment Chronic Idiopathic Urticaria (CIU).

Secondary Outcome Measures:

· To expand the information on the safety and tolerability of rupatadine as compared to placebo.
· Safety will be assessed by adverse event reports, laboratory parameters and physical examination.

Estimated Enrollment:	248
Study Start Date:	October 2002
Estimated Study Completion Date:	December 2003

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 with placebo for relief of CIU symptoms.

Methodology: A dose-finding multicentre, double-blind, randomised, placebo-controlled, parallel–group study Number of patients (planned and analysed): 248 patients. 62 patients will be allocated to each treatment group. 283 patients were randomised and analysed.

Diagnosis and criteria for 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.

Test product, dose, mode of administration, batch N°: Rupatadine 5,10 and 20 mg tablets; oral dose of 1 tablet/day for 4 consecutive weeks; batch 0102 (France) and batch 0203 (Hungary, Romania and Argentina). Expiry date: 12/2003 (France) and 10/2004 (Hungary, Romania and Argentina).

Duration of treatment: Oral administration of test formulation (5, 10, 20 mg) or placebo daily, for 4 consecutive weeks.

Reference therapy: Placebo tablets, 1 tablet/day for 4 consecutive weeks. Criteria for evaluation (efficacy): 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-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 and the interference with sleep and daily activities due to urticaria symptoms Criteria for evaluation (safety): AEs, laboratory tests and vital signs

Eligibility

Ages Eligible for Study:	12 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199238

Locations

France
Hospital Saint Louis
Paris Cedex 10, France, 75475

Sponsors and Collaborators

J. Uriach and Company

Investigators

Study Director:

EVA Arnaiz, PhD

J. Uriach y Compañía

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00199238 History of Changes
Other Study ID Numbers:	2002/47
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
Health Authority:	France: Afssaps - French Health Products Safety Agency; Romania: State Institute for Drug Control; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by J. Uriach and Company:

ANTIHISTAMINE
RUPATADINE
WHEAL
FLARE
DERMATOLOGY

Additional relevant MeSH terms:

Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists

Histamine
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine Agonists

ClinicalTrials.gov processed this record on February 09, 2012