Evaluation of the effectiveness and tolerability of Bilastine vs Fexofenadine vs Levocetrizine in patients with long term (Chronic)spontaneous urticaria.

Phase 4

Completed

• Conditions: Health Condition 1: - Health Condition 2: L508- Other urticaria

• Registration Number: CTRI/2020/03/024244
• Lead Sponsor: B J Medical College Civil Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.Both males and females patients aged � 18 years and � 60 years

2.Patients with H/O CSU

3.UAS7 of �7 at baseline

4.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol.

5.Patients who the study staff deems reliable and mentally competent to carry out the study.

Exclusion Criteria

1.Patients with physical urticaria (e.g. solar, heat, cold, aquagenic, cholinergic, contact, pressure, etc.), drug-induced urticaria, urticarial vasculitis, senile pruritus or hereditary angioedema.

2.Patients with any other dermatological condition associated with pruritus.

3.Pregnant or nursing females.

4.Patients with known hypersensitivity to the study drugs.

5.Patients with immunosuppressive disease or on immunosuppressive drugs.

6.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectââ?¬•s safety or interfere with the study assessments.

7.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the patientââ?¬•s ability to safely complete the study.

8.History of drug or alcohol dependency or abuse within approximately the last 2 years.

9.Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oComparison of effects of standard dose of Bilastine, Fexofenadine and Levocetrizine on disease activity in patients with chronic spontaneous urticaria <br/ ><br>oComparison of effects of double dose of Bilastine and Fexofenadine and Levocetrizine + Hydroxyzine on disease activity in patients with chronic spontaneous urticaria <br/ ><br>Timepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
�Safety Endpoints <br/ ><br>oThe incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal will be summarized by treatment groups <br/ ><br>oDegree of sleepiness of individual drug using VAS questionnaire <br/ ><br>Timepoint: 4 weeks;oPercentage of patients becoming symptom free at each visits in all groups <br/ ><br>oComparison of improvement in quality of life of patients in all groups. <br/ ><br>Timepoint: 4 weeks