Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: Bilastine 40 mg Tablets: Bilastine 40 mg Tablets Once daily for 28 Days
Control Intervention1: Bilastine 20 mg Tablets: Bilastine 20 mg Tablets Once daily for 28 Days
Control Interventi
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all the following criteria will be included in the study: 1.Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control during the duration of study) patients with age ranging from 18 to 65 years (both inclusive). 2.Having clinically confirmed diagnosis of chronic spontaneous urticaria characterized by erythematous skin wheals accompanied by itching attributable to no identifiable cause and occurring regularly at least three times per week for 6 weeks prior to entry in the study. 3.Having a symptom score of >2 (i.e, moderate-to-severe intensity scores) for any of two of the three features of pruritus, number of wheals, or maximum size of wheals (rated on pre-defined scales of 0 to 3) for at least 3 days during the screening visit (Day-7) and randomization visit (Day 1). 4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: Subject will be excluded from the study for any of the following reasons: 1.Patients with a history of any dermatological condition (including isolated hereditary angioedema, dermographism, physical urticaria, urticaria caused by a medicine or food allergy, infectious urticaria, contact urticaria, urticaria caused by vasculitis and/or collagenosis, paraneoplastic urticaria, parasitary urticaria, urticaria related with thyroid pathology, eczema or atopic dermatitis), which could interfere in the evaluation of the chronic spontaneous urticaria. 2.Patients with a history of autoimmune disorders, Hodgkinâ??s disease and any clinically signi ?cant condition (cardiovascular, neurological, hepatic, renal or malignant diseases). 3.Patients who had taken systemic or topical corticosteroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, any other systemic antihistamine (including loratadine, desloratadine, ebastine, rupatadine, mizolastine, cetirizine or levocetrizine) within 3 days, anti-leukotrienes within 3 days, sodium cromoglycate or nedocromil within 2 weeks, and tricyclic antidepressants within 1 week of randomization. 4.Patients with hypersensitivity to H1-antihistamines, benzimidazoles or lactose. 5.Known hypersensitivity to the drug components (study drug or excipient) used during the study. 6.Pregnant or lactating women. 7.Subjects with evidence of skin conditions that would interfere with clinical assessments in the opinion of the investigator. 8.Subjects with active substance abuse or a history of substance abuse within 6 months prior to Screening. 9.Subjects with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections. 10.Subject who have used any investigational drug or device within 30 days of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study. 11.Any observational finding (clinical evaluation / physical) that is interpreted by the investigator as a risk to the research participantâ??s participation in the clinical trial. 12.Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Bilastine 40mg when used for the treatment of chronic spontaneous urticaria. Timepoint: Day -7, Day 1, Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Bilastine 40mg when used for the treatment of chronic spontaneous urticaria.Timepoint: Day -7, Day 1, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr R M Chhabra
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed