A clinical trial to study the effects of two drugs, sustained release hydroxyzine and immediate release hydroxyzine in the treatment of patients with chronic idiopathic urticaria.

Phase 3

Completed

Registration Number: CTRI/2009/091/000788

Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female patients aged from 18 to 65 years.
2. Patients having minimum 6 weeks history of chronic idiopathic urticaria and were experiencing an active flare.
3. Patient willing to give their informed consent.

Exclusion Criteria

1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2. Patients having hypersensitivity to Hydroxyzine.
3. Patients taking pharmacological agents that could interfere with the study drug or interpretation of efficacy.
4. Patients with asthma using leukotriene inhibitors or those requiring chronic inhaled or systemic corticosteroid therapies.
5. Patients with uncontrolled hypertension and/or diabetes.
6. Alcohol abused patients.
7. Patients having porphyria.
8. Patients with renal and hepatic failure.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average change from baseline in following parameters:<br>1. Severity of pruritus over last 24 hours. <br>2. Rating of number of wheals. <br>3. Rating of average size of the wheals. <br>4. Rating of duration of pruritus per day.<br>Timepoint: Baseline Visit (day 0), week 2 and week 4

Secondary Outcome Measures

Name	Time	Method
1. Assessment of rating of sleep disturbance (difficulty in falling asleep due to itch, awakening due to itch, use of sleep medication).<br>2. Average change from baseline in Clinical Global Impression on Severity (CGI-S).<br>3. Evaluation of Clinical Global Impression on Improvement (CGI-I).Timepoint: 1. Baseline Visit (day 0), week 2 and week 4<br>2. Baseline Visit (day 0) and week 4<br>3. week 2 and week 4