Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT00199251
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
Study:
NCT00199251
Study Brief:
Protocol Section:
NCT00199251