| CTRI Number |
CTRI/2017/10/010232 [Registered on: 27/10/2017] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of bepotastine besilate and levocetrizine in urticaria disease of skin |
|
Scientific Title of Study
|
Randomized open label parallel comparative study of efficacy tolerability and safety of bepotastine besilate 20mg versus levocetrizine 5mg in patients with chronic spontaneous urticaria in a tertiary care centre |
| Trial Acronym |
Bplu |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri E |
| Designation |
2nd Year MD Post Graduate |
| Affiliation |
Sri Ramachandra Medical College and Research Institute, Chennai |
| Address |
Department of Pharmacology, 3rd Floor, Medical College Block, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, Porur, Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
7358512767 |
| Fax |
|
| Email |
gayathrianu2305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Punnagai |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Medical College and Research Institute, Chennai |
| Address |
Department of Pharmacology, 3rd Floor, Medical College Block, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, Porur, Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9840574080 |
| Fax |
|
| Email |
punnagaiguna@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri E |
| Designation |
2nd Year MD Post Graduate |
| Affiliation |
Sri Ramachandra Medical College and Research Institute, Chennai |
| Address |
Department of Pharmacology, 3rd Floor, Medical College Block, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, Porur, Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
7358512767 |
| Fax |
|
| Email |
gayathrianu2305@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Institute, Porur, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr E Gayathri |
| Address |
Department of Pharmacology, 3rd Floor, Medical College Block, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, Porur, Chennai |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri E |
Sri Ramachandra Hospital |
Second floor, Dermatology opd,Sri Ramachandra hospital,porur,Chennai
Kancheepuram
TAMIL NADU |
7358512767
gayathrianu2305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra University, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L500||Allergic urticaria, diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bepotastine besilate 20mg |
bepotastine besilate is used in allaergic rhinitis and and allergic conjuctivitis.so we are trying to finf off label use of bepotastione in urticaria |
| Comparator Agent |
levocetrizine 5mg |
Levocetrizine 5 mg is used in urticaria. it is an antihistamine so we are going to compare both levocetrizine with bepotastine besilate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients, aged 18-70 years old, with a diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited.
Eligible patients should demonstrate Symptom score of ≥2 (i.e. moderate to severe intensity UAS7 scores) during the baseline visit.
Patients willing to give informed consent will be included.
|
|
| ExclusionCriteria |
| Details |
Patients excluded from the study if they have any dermatological condition that could interfere with the efficacy evaluation (including eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitization dermatitis, asteatotic eczema, lichen simplex chronicus, angioedema, , urticaria with known causes, urticaria related to thyroid disorders, urticaria pigmentosa, psoriasis, or ichthyosis
o Known hypersensitivity to antihistamine,
o Known autoimmune disorders, Hodgkins disease
o Any clinically significant condition (cardiovascular, neurological, hepatic, renal, or malignant diseases),
o Received ultraviolet light therapy before entry.
o Similarly, patients who had received antihistamines (including H2 receptor antagonists) within 3 days, nonsteroidal anti-inflammatory drugs within 3 days, topical or systemic steroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, anti-Leukotrienes within 3 days.
o Pregnant and lactating women.
o Subject who is currently enrolled in another investigational drug study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is the change from baseline in mean weekly Urticaria activity score-7( i.e the sum of the daily UAS i.e.(sum of wheal & itching day and night time score) self evaluation scores of 7 individual days,which could range between 0 to 42 per week) after 4 weeks of treatment
|
five time points-patients will be analyased during baseline and after every 7 days for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to onset of action will be determined by comparing Bepotastine besilate with Levocetrizine by using participant’s daily scoring chart.
C-reactive protein and Absolute Eosinophil count will be evaluated during the baseline visit and end of therapy for predicting the outcome of treatment with Bepotastine. 2.Chronic Urticaria quality of life questionnaire
3.Dermatology life quality index
4. Patients global assessment of their symptoms
|
two time points-patients will be analyased during baseline and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
. The patients will be assessed for the following
scales before the beginning of study, during the course of treatment and at the
end of study.
1. Urticaria Activity score
2. Chronic Urticaria quality of life questionnaire
3. Dermatology life quality index
4. Patients global assessment of their symptoms
5. Clinical Global Impression – Global Improvement (CGI –I) Scale
Visual
analogue scale measuring day time sedation |