Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199238
Status:
TERMINATED
Last Update Posted:
2022-02-18
First Post:
2005-09-12
Brief Title:
Efficacy of Rupatadine 5 10 and 20 mg in Chronic Idiopathic Urticaria
Sponsor:
J Uriach and Company
Organization:
J Uriach and Company
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptomsTo 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 symptomsTo 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 510 and 20 mg tablets oral dose of 1 tabletday for 4 consecutive weeks batch 0102 France and batch 0203 Hungary Romania and Argentina Expiry date 122003 France and 102004 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 tabletday 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 periodSecondary 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
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 510 and 20 mg tablets oral dose of 1 tabletday for 4 consecutive weeks batch 0102 France and batch 0203 Hungary Romania and Argentina Expiry date 122003 France and 102004 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 tabletday 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 periodSecondary 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None