CTRI/2020/11/029215 [Registered on: 18/11/2020] Trial Registered Prospectively
Last Modified On:
04/09/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To evaluate the effectiveness and safety of non sedating anti allergics for the treatment of Chronic Spontaneous Urticaria
Scientific Title of Study
A Phase III Multicentric Randomized Double Blind Parallel Group Comparative Clinical Study to Evaluate the Efficacy and Safety of Bilastine Tablets 40 mg for the Treatment of Chronic Spontaneous Urticaria
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
ICS/SYN/2020-001 Version 2.0 Dated 24 Jun 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr R M Chhabra
Designation
Medical Monitor/Trial Coordinator
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
Insignia Clinical Services Pvt. Ltd.
Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura Insignia Clinical Services Pvt. Ltd.
Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West DELHI 110034 India
Phone
011-49049115
Fax
011-49049115
Email
Chhabradrrm@gmail.com
Details of Contact Person Scientific Query
Name
Dr R M Chhabra
Designation
Medical Monitor
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
Insignia Clinical Services Pvt. Ltd.
Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura Insignia Clinical Services Pvt. Ltd.
Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West DELHI 110034 India
Phone
011-49049115
Fax
011-49049115
Email
Chhabradrrm@gmail.com
Details of Contact Person Public Query
Name
Dr R M Chhabra
Designation
Medical Monitor
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
Insignia Clinical Services Pvt. Ltd.
Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura Insignia Clinical Services Pvt. Ltd.
Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West DELHI 110034 India
Phone
011-49049115
Fax
011-49049115
Email
Chhabradrrm@gmail.com
Source of Monetary or Material Support
Synokem Pharmaceuticals Ltd
14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi - 110087
Primary Sponsor
Name
Synokem Pharmaceuticals Ltd
Address
14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi - 110087, India
SMS Medical College and Attached Hospitals Ethics Commitee
Approved
Society for Academic, Scientific & Translational Research Advancement
Approved
Society for Academic, Scientific & Translational Research Advancement
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L501||Idiopathic urticaria,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Bilastine 20 mg Tablets
Bilastine 20 mg Tablets Once daily for 28 Days
Intervention
Bilastine 40 mg Tablets
Bilastine 40 mg Tablets Once daily for 28 Days
Comparator Agent
Levocetrizine 10 mg Tablets
Levocetrizine 10 mg Tablets Once daily for 28 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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, Hodgkin’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 participant’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).
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Other
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
To evaluate the safety of Bilastine 40mg when used for the treatment of chronic spontaneous urticaria.
Day -7, Day 1, Day 14, Day 28
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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 patient‟s 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:
 the change from randomization visit (Day 1) in the patients‟ and investigators mean instantaneous total and individual symptoms scores;
 the change from randomization visit (Day 1) in the patients‟ DLQI scores;
 the patients‟ VAS scores;
 the patients‟ impact of urticaria on sleep scores;