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Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria

Primary Purpose

URTICARIA

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Rupatadine Fumarate
Sponsored by
J. Uriach and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for URTICARIA focused on measuring ANTIHISTAMINE, RUPATADINE, WHEAL, FLARE, DERMATOLOGY

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Saint Louis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

rupatadine 5mg

rupatadine 10 mg

rupatadine 20 mg

Arm Description

Once daily/ 28 days

Once daily/ 28 days

Once daily/ 28 days

Once daily/ 28 days

Outcomes

Primary Outcome Measures

Pruritus
change in mean pruritus score (MPS) over the 4-week treatment period.

Secondary Outcome Measures

Wheals
change in mean number of wheals score (MNW) over the 4-week treatment period.
change in mean total symptoms score (MTSS) over the 4-week treatment period.
overall impression
overall impression for efficacy was done by the investigator and by the patient

Full Information

First Posted
September 12, 2005
Last Updated
February 2, 2022
Sponsor
J. Uriach and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00199238
Brief Title
Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Study Start Date
October 28, 2002 (Actual)
Primary Completion Date
November 25, 2003 (Actual)
Study Completion Date
September 27, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
J. Uriach and Company

4. Oversight

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
URTICARIA
Keywords
ANTIHISTAMINE, RUPATADINE, WHEAL, FLARE, DERMATOLOGY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily/ 28 days
Arm Title
rupatadine 5mg
Arm Type
Experimental
Arm Description
Once daily/ 28 days
Arm Title
rupatadine 10 mg
Arm Type
Experimental
Arm Description
Once daily/ 28 days
Arm Title
rupatadine 20 mg
Arm Type
Experimental
Arm Description
Once daily/ 28 days
Intervention Type
Drug
Intervention Name(s)
Rupatadine Fumarate
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pruritus
Description
change in mean pruritus score (MPS) over the 4-week treatment period.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Wheals
Description
change in mean number of wheals score (MNW) over the 4-week treatment period.
Time Frame
4 weeks
Title
change in mean total symptoms score (MTSS) over the 4-week treatment period.
Time Frame
4 weeks
Title
overall impression
Description
overall impression for efficacy was done by the investigator and by the patient
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EVA Arnaiz, PhD
Organizational Affiliation
J. Uriach y Compañía
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17478385
Citation
Dubertret L, Zalupca L, Cristodoulo T, Benea V, Medina I, Fantin S, Lahfa M, Perez I, Izquierdo I, Arnaiz E. Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study. Eur J Dermatol. 2007 May-Jun;17(3):223-8. doi: 10.1684/ejd.2007.0153. Epub 2007 May 4.
Results Reference
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Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria

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