Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00199251
Status:
TERMINATED
Last Update Posted:
2005-12-23
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rupatadine 10 and 20 Mg in Chronic Idiopathic Urticaria
Sponsor:
J. Uriach and Company
Organization:
Study Overview
Official Title:
A 6-Week Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Rupatadine 10 and 20 Mg in the Treatment of Chronic Idiopathic Urticaria (CIU): a Phase III Clinical Trial
Status:
TERMINATED
Status Verified Date:
2005-09
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:
· 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.
Detailed Description:
STUDY PHASE III OBJECTIVES · To evaluate the efficacy and safety of rupatadine 10 mg and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
DESIGN · A multicentre, double blind, randomised, placebo controlled, parallel-group study in 300 patients (100 patients each treatment) group.
INDICATION · Chronic Idiopathic Urticaria (CIU) ASSESSMENT 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 and 6-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, severity of symptoms of CIU as measured by the patient in terms of change in mean pruritus score (MPS) over the 6-week treatment period, Visual Analogic Scale (VAS) and Quality of life (QoL) which will be assessed by the "Dermatology Life Quality Index" (DLQI).Safety: ECGs baseline and final visit; clinical laboratory controls, physical examination, incidence of adverse events (AE).
STUDY POPULATION 300 patients between 12-65 years of age, with CIU
DESIGN · A multicentre, double blind, randomised, placebo controlled, parallel-group study in 300 patients (100 patients each treatment) group.
INDICATION · Chronic Idiopathic Urticaria (CIU) ASSESSMENT 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 and 6-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, severity of symptoms of CIU as measured by the patient in terms of change in mean pruritus score (MPS) over the 6-week treatment period, Visual Analogic Scale (VAS) and Quality of life (QoL) which will be assessed by the "Dermatology Life Quality Index" (DLQI).Safety: ECGs baseline and final visit; clinical laboratory controls, physical examination, incidence of adverse events (AE).
STUDY POPULATION 300 patients between 12-65 years of age, with CIU
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: