| CTRI Number |
CTRI/2021/07/034899 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to investigate the effect of fixed dose combination of Bilastine plus Montelukast Oral Suspension for the treatment of allergic rhinitis in children aged 6 to 11 years. |
|
Scientific Title of Study
|
“A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group and Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Bilastine 10 mg plus Montelukast 4 mg Oral Suspension Versus FDC of Levocetirizine 2.5 mg plus Montelukast 4 mg Oral Suspension in patients with allergic rhinitis.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/20/007 |
Protocol Number |
| Version No. 00 & Dated Dec 04, 2020 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotsna Seepana |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College & Government General Hospital (Old RIMSGGH) |
| Address |
Department of Paediatircs, Government Medical College & Government General Hospital (Old RIMSGGH).
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drjyotsnaggh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd., H.I.G-19, H.NO: 1-19-25/19,
4th Floor, Above Karur Vysya Bank,
Dr. A. S. Rao Nagar.
Hyderabad
TELANGANA
500062
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Surender Kumar Arora |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd.,
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi
DELHI
110087
India |
| Phone |
9811015684 |
| Fax |
|
| Email |
ska@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd., 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Sivaram Prasad |
Gandhi Medical College and Hospital |
In-Patient Block,
Ground Floor,
Department of Pediatrics, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA |
9440424545
sivaram175@yahoo.com |
| Dr Jyotsna Seepana |
Government Medical College & Government General Hospital (Old RIMSGGH) |
Department of Paediatircs, Srikakulam-532001.
Srikakulam
ANDHRA PRADESH |
8942279033
drjyotsnaggh@yahoo.com |
| Dr Yashwant Kumar Rao |
GSVM Medical College |
Department of Pediatrics,
Swaroop Nagar,
Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
9919080807
ykraoneo@yahoo.co.in |
| Dr Jai Prakash Narayan |
Jawahar Lal Nehru (J.L.N) Medical College |
Department of Pediatrics,
Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN |
9314294402
narayan_jaiprakash@yahoo.co.in |
| Dr Vinay Kumar Gill |
Maharaja Agrasen Superspeciality Hospital |
Department of Clinical Research,
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN |
9252101110
mahclinical@gmail.com |
| Dr Kalpana Datta |
Medical College and Hospital |
Department of Pediatrics,
MCH Building,
4th Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL |
9836424144
drkalpanadatta@gmail.com |
| Dr Rajarshi Basu |
Nil Ratan Sarkar Medical College and Hospital |
Department of Pediatrics,
138, Acharya Jagadish Chandra Bose Road, Sealdah, Raja Bazar,
Kolkata-700014.
Kolkata
WEST BENGAL |
9830196935
rajarshibose.kolkata@gmail.com |
| Dr Sangita Mahendra Kumbhojkar |
Rajarshee Chhatrapati Shahu Maharaj GMC and Chhatrapati Pramila Raje General Hospital |
Department of Pediatrics,
Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002.
Kolhapur
MAHARASHTRA |
7775026777
rcsmgmc.research@gmail.com |
| Dr A Srimukhi |
Vignesh Women & Child Care |
Department of Clinical Research,
#32-6-18C, Prajasakthinagar, Sikhamani Center, Vijayawada-520010.
Krishna
ANDHRA PRADESH |
7799867867
dr.srimukhianumolu@gmail.com |
| Dr Sanket Goyal |
W Pratiksha Hospital |
Department of Clinical Research,
Golf Course Ext. Road, Sushant Lok II,
Sector 56, Gurugram-122011.
Gurgaon
HARYANA |
9717675252
sanketgoyal007@gmail.com |
| Dr S Chandramohan Reddy |
Zydus Medical College and Hospital |
Department of Paediatrics,
Opp. Nehru Baug, Station Road, Dahod-389151.
Dohad
GUJARAT |
9947602407
drcmreddy81@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee, GSVM Medical College |
Approved |
| Ethics Committee, Nil Ratan Sarkar Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research Medical College |
Approved |
| Institutional Ethics Committee, Anu Hospitals |
Approved |
| Institutional Ethics Committee, Gandhi Medical College / Hospital |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH), |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Institutional Ethics Committee, Zydus Medical College and Hospital |
Submittted/Under Review |
| Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2) |
Approved |
| North East Healthcare Private Limited, W Pratiksha Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Bilastine 10 mg plus Montelukast 4 mg Oral Suspension |
Patients will be advised to take 5 mL of oral suspension once a day orally one hour before or two hours after meals around same time every day for 2 weeks. |
| Comparator Agent |
FDC of Levocetirizine 2.5 mg plus Montelukast 4 mg Oral Suspension |
Patients will be advised to take 5 mL of oral suspension once a day orally one hour before or two hours after meals around same time every day for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 6 and 11 years (both inclusive).
2. Patients with a history of allergic rhinitis, a positive skin prick test to at least one relevant allergen and active symptoms of allergic rhinitis at study entry.
3. Patients with elevated serum IgE levels (>100 IU/mL) at screening or baseline visit.
4. Patients with Total Nasal Symptom Score (TNSS) at screening or baseline ≥ 4.
5. Written informed assent or oral consent from the patient, legally acceptable representative or parent and able to follow study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
3. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit.
4. Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases.
5. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL].
6. Patients who had initiation of allergen immunotherapy within previous 6 months.
7. Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
8. Patients with history of nasal polyps or any clinically important nasal anomaly.
9. Patients with history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
10. Patients with history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
11. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
12. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to screening visit.
13. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
14. Suspected inability or unwillingness to comply with the study procedures. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Non-Nasal symptom score (TNNSS)] at the end of study as compared to baseline. |
At Day 1, Day 7 and Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The change in Total nasal symptom score (TNSS) at the end of study as compared to baseline. |
At Day 1, Day 7 and Day 14. |
| The change in Total non-nasal symptom score (TNNSS) at the end of study as compared to baseline. |
At Day 1, Day 7 and Day 14. |
| The assessment of safety of patients [comparison of incidence of treatment emergent adverse event (TEAE)]. |
Throughout the study. |
| The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values. |
AE & SAE - Throughout the study.
Laboratory Values - Day 1 and Day 14. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "212"
Final Enrollment numbers achieved (India)="212" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/07/2021 |
| Date of Study Completion (India) |
22/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
trial is a phase III, prospective, randomized,
double blind, active-controlled, comparative, parallel group and multicentric
clinical study to evaluate the efficacy, safety and tolerability of FDC of
Bilastine 10 mg + Montelukast 4 mg Oral Suspension versus FDC of Levocetirizine
2.5 mg + Montelukast 4 mg Oral Suspension in patients with allergic rhinitis.
Patients
who are willing and able to participate in the study will sign and date the
Informed Assent Form or Oral assent in the presence of his/her parent or LAR on
the day of screening / baseline visit (Visit 1). During this screening period, patients
who are willing to give informed assent or oral assent will be evaluated for
all the eligibility criteria. Eligible patients aged between 6 to 11 years
(both inclusive) with a history of allergic rhinitis, a positive skin prick
test to at least one relevant allergen and active symptoms of allergic rhinitis
at study entry, elevated serum IgE levels (>100 IU/mL) and Total Nasal Symptom
Score (TNSS) at baseline ≥ 4 will be considered for the study.
After confirming the inclusion/exclusion criteria the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on week 1/day 7(±2) and week 2/day 14(±2) (Final
Visit) of treatment to assess efficacy and safety.
Patients
will be assigned to either of the two arms i.e. Arm A or Arm B consisting of FDC
of Bilastine 10 mg + Montelukast 4 mg Oral Suspension or FDC of Levocetirizine 2.5
mg + Montelukast 4 mg Oral Suspension. Patients will be advised to take 5 mL of
oral suspension once a day orally one hour before or two hours after meals
around same time every day for 2 weeks. |