To evaluate the effectiveness and safety of non sedating anti allergics for the treatment of Chronic Spontaneous Urticaria

Phase 3

Active, not recruiting

Conditions: Idiopathic urticaria,

Registration Number: CTRI/2020/11/029215

Lead Sponsor: Synokem Pharmaceuticals Ltd

Brief Summary: This is a Phase III, Multicentric, Comparative, Randomized, Double blind, Parallel group

clinical study to evaluate the efficacy and safety of Bilastine Tablet 40mg once daily Vs.

Bilastine Tablet 20mg Vs. Levocetrizine Tablet 10 mg once daily when used in treatment

of subjects with chronic spontaneous urticaria.

Male and female subjects between 18 to 65 years (both inclusive) with 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 will be screened for eligibility to participate in the study. Eligible patients will be additionally required to demonstrate 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) will be enrolled for treatment and randomized in any of the treatment groups (Bilastine 40mg vs. Bilastine 20mg vs. Levocetrizine 10mg) in a 1:1:1 ratio.

EVALUATION OF SAFETY: An adverse event is defined as any untoward medical occurrence (sign, symptom or laboratory finding), regardless of severity and whether or not attributed to the investigational product. All adverse events, whether observed by an Investigator or Study Coordinator or reported by the subject, whether related to study drug or not related to study drug, shall be documented on the CRF and subject records, together with details, i.e. date of onset, the duration and intensity of each episode, the action taken, the relationship to the investigational product and the degree of severity, the seriousness and the outcome. Safety and tolerability to treatment were evaluated according to routine laboratory tests (haematology and biochemistry), 12-lead ECGs, clinical examinations, and the incidence, severity and type of AEs reported by the patients over the course of treatment. All AEs were coded using the Medical Directory for Regulatory Activities (MedDRA) and grouped by treatment. The number and percentage of AEs, SAEs, AEs leading to discontinuation, and AEs related to study drug will be summarized by system organ class, preferred term and treatment group. The number and percentage of AEs by severity will also be summarized. All AEs will be displayed in listings. No inferential analyses are planned. Summary of vital signs, laboratory parameter values at relevant time points as well as change from baseline will be presented. Summary of physical examination findings will be presented by visit. Summary of concomitant medications will be presented. Safety evaluations in the study will be performed using Safety Analysis Set (SAF). The Safety Analysis Set (SAF) consists of all subjects who took at least 1 dose of study medication, and will be used for safety analyses.

A descriptive analysis comparing the adverse events in both the treatment groups will be performed.

EVALUATION OF EFFICACY: The primary efficacy parameter will be:

Change from baseline in the patientâ€Ÿs reflective daily total symptoms score (TSS) over the 28-day treatment period, with baseline defined as the mean of the 3 days with maximum symptoms before randomization.

The secondary efficacy parameters include effect after 2-4 weeks treatment on:

ï‚· the change from randomization visit (Day 1) in the patientsâ€Ÿ and investigators mean instantaneous total and individual symptoms scores;

ï‚· the change from randomization visit (Day 1) in the patientsâ€Ÿ DLQI scores;

ï‚· the patientsâ€Ÿ VAS scores;

ï‚· the patientsâ€Ÿ impact of urticaria on sleep scores;

ï‚· the investigatorâ€Ÿs GCI of treatment.

**Test & Comparator Groups:**

Test product (Arm 1): Bilastine Tablets 40mg

Comparator Product (Arm 2): Bilastine Tablets 20mg Comparator Product (Arm 3): Levocetrizine Tablets 10mg

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 200

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

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 signiï¬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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Bilastine 40mg when used for the treatment of chronic spontaneous urticaria.	Day -7, Day 1, Day 14, Day 28

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of Bilastine 40mg when used for the treatment of chronic spontaneous urticaria.	Day -7, Day 1, Day 14, Day 28

Trial Locations

Locations (7): Govt. Medical College & Govt. General Hospital(Old RIMSGGH)
🇮🇳
Srikakulam, ANDHRA PRADESH, India
Jaipur Golden Hospital
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West, DELHI, India
King George Hospital
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Visakhapatnam, ANDHRA PRADESH, India
Santosh Medical College Hospital
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Ghaziabad, UTTAR PRADESH, India
Shubham Sudbhawana Supespeciality Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Skinnovate Institute for Health & Reserach
🇮🇳
Pune, MAHARASHTRA, India
SMS Medical College and Attached Hospitals
🇮🇳
Jaipur, RAJASTHAN, India
Govt. Medical College & Govt. General Hospital(Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, India
Dr M Asha
Principal investigator
9912320517
MuralidharGudla@yahoo.com