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CTRI Number  CTRI/2019/09/021293 [Registered on: 17/09/2019] Trial Registered Prospectively
Last Modified On: 12/09/2019
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 comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg plus Montelukast sodium 5mg/10mg tablet versus Montelukast sodium 5mg and Montelukast sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis. 
Scientific Title of Study   A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg + Montelukast sodium 5mg/10mg tablet versus Montelukast Sodium 5mg and Montelukast Sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
WIN/CT/007/BEP/MON/2018, Version 1.0 Dated 11th July, 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mukesh Kumar 
Designation  Director- Clinical Operation 
Affiliation  RAHE 
Address  A 19 Gurunanakpura, Laxmi Nagar, Near Nirman Vihar Metro Station

North East
DELHI
110092
India 
Phone  9873038019  
Fax    
Email  mukesh@rahelife.com  
 
Details of Contact Person
Scientific Query  
Name  Mukesh Kumar 
Designation  Director- Clinical Operation 
Affiliation  RAHE 
Address  A 19 Gurunanakpura, Laxmi Nagar, Near Nirman Vihar Metro Station

North East
DELHI
110092
India 
Phone  9873038019  
Fax    
Email  mukesh@rahelife.com  
 
Details of Contact Person
Public Query  
Name  Mukesh Kumar 
Designation  Director- Clinical Operation 
Affiliation  RAHE 
Address  A 19 Gurunanakpura, Laxmi Nagar, Near Nirman Vihar Metro Station

North East
DELHI
110092
India 
Phone  9873038019  
Fax    
Email  mukesh@rahelife.com  
 
Source of Monetary or Material Support  
Windlas Biotech Pvt. Ltd. 
 
Primary Sponsor  
Name  Windlas Biotech Pvt Ltd 
Address  Dehradun 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debananda Sahoo  All India Institute of Medical Sciences  Department of Medicine, AIIMS, Sijua, Patrapada, Bhubaneswar Odisha
Khordha
ORISSA 		 8763290804

genmeddebananda@aiimsbhubaneswar.edu.in 
Dr T Jaya Prakash  Anu Hospital  Kovelamudi Vari Street suryaraopet, vijayawada krishna
Krishna
ANDHRA PRADESH 		 9440668304

docjapee@rediffmail.com 
Dr Sunil Naik  Government Medical College and Government General Hospital  Department of Medicine, Government Medical College and Government General Hospital, Shanti Nagar Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH 		 8942279033

rimssearch@rediffmail.com 
Dr Abhinav Rathi  JNUIMSRC  Department of ENT, JNUIMSRC, Jagatpura, Jaipur, Rajasthan 302017
Jaipur
RAJASTHAN 		 014171990072

advisoroffice@jnujaipur.ac.in 
Dr Yogesh Kumar Kansal  Maharaja Agrasen Hospital  West Punjabi Bagh New delhi
West
DELHI 		 7011558846

yogesh07kansal@gmail.com 
Dr Ishwar Singh  Maulana Azad Medical College  Room No 329, 3rd floor, Taneja block, Jawaharlal Nehru Marg, New Delhi
Central
DELHI 		 7834846143

clinsresearch@gmail.com 
Dr Indraneel Basu  Popular Hospital  N 10/60 A2, DLW Road kakarmatta Varanasi
Varanasi
UTTAR PRADESH 		 9935036063

dribasumd@yahoo.co.in 
Dr Indernath Kundu  R G Kar Medical College and Hospital  Department of ENT, 1, Khudiram Bose Sarani, Kolkata 700004 West Bengal
Kolkata
WEST BENGAL 		 9830035217

drinkundu@rediffmail.com 
Dr Devendra Kumar Singh  Sharda hospital, SMSR, Sharda University  Department of Respiratory Medicine, Sharda hospital, Knowledge park-III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9911455019

cr@shardahospital.org 
Dr Jitendra Singh  Sudbhawana Hospital  B 31/80, Bhogabir, Lanka, Varanasi
Varanasi
UTTAR PRADESH 		 7776808121

drjitengsvm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics committee Sadbhawana hospital  Submittted/Under Review 
IEC Anu Hospital  Submittted/Under Review 
IEC Maharaja Agrasen Hospital  Submittted/Under Review 
IEC MAMC  Submittted/Under Review 
Institutional Ethics Committee SMSR Sharda University  Approved 
Institutional Ethics Committee AIIMS Bhubaneswar Orissa  Submittted/Under Review 
Institutional Ethics Committee JNUIMSRC Jagatpura Jaipur Rajasthan  Submittted/Under Review 
Institutional Ethics Committee R G Kar Medical College and Hospital Kolkata  Submittted/Under Review 
Institutional Ethics Committee RIMS Srikakulam Andhra Pradesh  Approved 
Popular hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J393||Upper respiratory tract hypersensitivity reaction, site unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bepotastine besilate plus Montelukast sodium  Bepotastine Besilate 10mg/10mg plus Montelukast Sodium 5mg/10mg in tablet form and administered orally once a day for the duration of 14 days. 
Comparator Agent  Montelukast sodium  Montelukast Sodium 5mg and Montelukast Sodium 10mg in tablet form and administered orally once a day for the duration of 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects who meet the following criteria are eligible for inclusion in the study:
1.Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
2.Male and Female subjects of group age ≥18 to ≤65 years.
3.Patient with symptoms of allergic rhinitis characterized by nasal pruritus, sneezing, rhinorrhea, and nasal congestion.
4.Patients with a Total Nasal Symptom Score (TNSS; the sum of all the 4 individual nasal symptom scores) of 6 or greater and/or a Total Ocular Symptom Score (TOSS; the sum of all the 3 individual ocular symptom scores) of 4 or greater and rhinitis symptoms.
5.Except Allergic Rhinitis disorders patient is judged to be in general good health based on medical history, physical examination and laboratory tests as assessed by the Investigator.
6.Written informed consent signed by patient and willing to comply with the study procedure.
7.Female patient of childbearing potential definitely using effective contraception during the study and willing to undergo pregnancy test.

 
 
ExclusionCriteria 
Details  1.Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
2.Patients with known hypersensitivity to the study categories of medications.
3.Pregnant and lactating female patient.
4.Patient with known history of hypersensitivity to Bepotastine tablet or its components.
5.Patients receiving oral or topical H1 receptor antagonists within the last 48 hrs of enrolment.
6.Patients receiving antiallergic or antipruritic agents, antihistamines, corticosteroids, NSAIDs, tranquillizers and cold remedies within three days prior to the study.
7.Patients with upper respiratory tract infections within 30 days before the study
8.Rhinitis related to anatomic problems (polyps, septum deviation, etc.).
9.Patients with severe physical nasal obstruction or injury, nasal ulcers, recent nasal surgery, asthma, rhinitis medicamentosa, acute or chronic sinusitis, glaucoma, cataract, any psychiatric disorder, adrenal insufficiency, prostatism, diabetes mellitus and bacterial or viral infection within 2 weeks of participation in the study.
10.Patient with known and current use of alcohol or drug addiction.
11.Patient with previous participation in any clinical trial in past 1 month.
12.Any condition or concurrent severe disease that may preclude the patient from taking part in the clinical trial as per Investigator’s discretion.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy and safety of FDC of Bepotastine 10mg/10mg plus Montelukast Sod. 5mg/10mg in Indian patients diagnosed with Allergic Rhinitis.  Treatment Phase from Day 1 (Week 1) to day 14 (Week 2) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the number of subjects whose Allergic Rhinitis alleviated to normal in both groups (Study and Active Control).  Treatment Phase from Day 1 (Week 1) to day 14 (Week 2) 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg plus Montelukast Sodium 5mg/10mg Tablet versus Montelukast Sodium 5mg, Montelukast sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis. The efficacy of both Bepotastine besilate 10mg/10mg plus Montelukast Sodium 5mg/10mg as well as Bepotastine besilate 10mg are tested and proven in the treatment of Allergic rhinitis (Nasal congestion, rhinorrhoea, nasal pruritus, sneezing) as per available clinical data. Therefore, we are conducting this prospective clinical trial to determine the safety and efficacy of Bepotastine 10mg/10mg plus Montelukast Sodium 5mg/10mg, Montelukast Sodium 5mg, Montelukast Sodium 10mg tablets in Indian subjects. It would be a multi-centric clinical trial. We will adopt the consecutive enrolment, wherein each patient will be screened and enrolled into the study if found eligible.


 
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