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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00199238
Other study ID # 2002/47
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 28, 2002
Est. completion date September 27, 2004

Study information

Verified date February 2022
Source J. Uriach and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 248
Est. completion date September 27, 2004
Est. primary completion date November 25, 2003
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility Inclusion Criteria: 1. Man or woman aged between 12 and 65 2. 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 3. 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 4. Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator 5. Patient who signed the informed consent form - Exclusion Criteria: 1. CIU associated to some underlying disease (Hodgkin's disease/vasculitis/lupus erythematous/hepatitis) 2. 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. 3. Physical urticaria due to cold, heat, and/or sun 4. Cholinergic urticaria 5. 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. 6. Urticaria due to known aetiology (e.g., medications, insects bites, food, etc) 7. Patient unresponsive to antihistaminic treatment 8. Patient with psychiatric disorders, vascular, hepatic, neurological, endocrine or other major systemic disease 9. Pregnant or lactating female 10. Patient with any heart abnormality of clinical relevance or any pathological changes of the heart rate 11. Patient under any medication which could interfere with drug effect or with interpretation of efficacy parameters 12. Subject handling dangerous machinery or driving as an integral part of his/her occupation 13. Patient with hereditary angioedema or isolated dermographism 14. Patient with disease caused by a parasite

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rupatadine Fumarate


Locations

Country Name City State
France Hospital Saint Louis Paris Cedex 10

Sponsors (1)

Lead Sponsor Collaborator
J. Uriach and Company

Country where clinical trial is conducted

France, 

References & Publications (1)

Dubertret L, Zalupca L, Cristodoulo T, Benea V, Medina I, Fantin S, Lahfa M, Pérez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pruritus change in mean pruritus score (MPS) over the 4-week treatment period. 4 weeks
Secondary Wheals change in mean number of wheals score (MNW) over the 4-week treatment period. 4 weeks
Secondary change in mean total symptoms score (MTSS) over the 4-week treatment period. 4 weeks
Secondary overall impression overall impression for efficacy was done by the investigator and by the patient 4 weeks
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