| CTRI Number |
CTRI/2017/06/008889 [Registered on: 21/06/2017] Trial Registered Prospectively |
| Last Modified On: |
23/11/2018 |
| 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 Trial to evaluate Efficacy and Safety of Bilastine Tablet 20 mg Vs. Levocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis |
|
Scientific Title of Study
|
A Comparative, Two arm, Randomized, Double blind, Parallel group, Non- Crossover, Multicentric Clinical Study to evaluate Efficacy, Safety and Tolerability of Bilastine Tablet 20 mg as compared with Levocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/14/07 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra Khippal |
| Designation |
Principal Investigator |
| Affiliation |
S.M.S. Medical College & Hospital, |
| Address |
Institute of Respiratory Diseases, S.M.S. Medical College & Hospital, B-2 Shubhash Nagar Shopping Centre, Shanti Nagar, Jaipur-302016, Rajasthan.
Jaipur
RAJASTHAN
302016
India |
| Phone |
|
| Fax |
|
| Email |
drnkhippal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Senior Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
2266062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Senior Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
2266062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Ltd
Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067. India |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate, Kandivli (West) Mumbai-400067 Maharashtra. India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Preetam |
All India Institute of Medical Sciences |
Dept of ENT,
Sijua, Bhubaneshwar - 751019, Odisha
Khordha
ORISSA |
9438884166
preetam82@gmail.com |
| Dr Vikas Pilaniya |
Apex Hospitals Pvt.Ltd |
SP-4 & 6, Malviya Industrial Area, Malviya Nagar
Jaipur
RAJASTHAN |
9811631346
vikaspilaniya@gmail.com |
| Dr Sanjeev Gupta |
Apollo Hospital |
Dept of ENT,
Plot No-251, Sainik School Road, Unit 15,
Bhubaneswar-751005.
Odisha.
Khordha
ORISSA |
80930602016
drsanjeev_g@apollohospitals.com |
| Dr Umesh Joshi |
Aster Aadhar Hospital |
Dept of ENT,
R.S.No-628, B ward, Near Shastri Nagar, KMT workshop, Kolhapur-416012.
Kolhapur
MAHARASHTRA |
9225068503
umeshjoshi.aacr@gmail.com |
| Dr Navneet Kumar |
Christian Medical College, |
Dept of ENT, Ludhiana-141008, Punjab
Ludhiana
PUNJAB |
9872990171
navneet_ent@rediffmail.com |
| Dhruba Jyoti Datta |
Down Town Hospital Ltd |
Dispur, GS Road, Guwahati-781006
Kamrup
ASSAM |
9864026560
0361-2331824
djdatta13@gmail.com |
| Dr Sharma Suktra Arvind |
GCS Medical College Hospital & Research Centre |
Dept of respiratory disease, Opp-DRM office, Near chamunda bridge, Naroada Road, Ahmdabad-380025, Gujarat.
Ahmadabad
GUJARAT |
9409286294
suktatasharma@yahoo.co.in |
| Dr Gattu Suresh Kumar |
Govt. Siddhartha Medical College |
Dept of Pulmonology,
Ring Road, Gunadala, Vijayawada – 520008.
Andhra Pradesh.
Krishna
ANDHRA PRADESH |
8374358304
sureshkumargattu@gmail.com |
| Dr Shrinivas Chavan |
Grant Govt. Medical College & Sir JJ Group of Hospitals |
Department of ENT,Byculla, Mumbai-400008.
Maharashtra.
Mumbai
MAHARASHTRA |
9922994226
shrinivasc77@hotmail.com |
| Dr V C Srinivas Reddy |
King George Hospital |
Department of Medicine,
Andhra Medical College, Visakhapatnam – 530002.
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH |
9703157774
kghresearch7@gmail.com |
| Dr Janardan Pisal |
KMRF‟S Nikop Hospital |
Dept of ENT,
Ring Road,
Phaltan – 415523.
Dist. Satara.
Maharashtra.
Satara
MAHARASHTRA |
9822037374
nikophospital59@gmail.com |
| Dr Tirpude Sneha Uttam |
KRIMS Hospital |
Dept of Pulmonology
275, Central Bazar Road, RamdasPeth,
Nagpur – 440010.
Maharashtra.
Nagpur
MAHARASHTRA |
9870578511
drsnehatirpude26@gmail.com |
| Dr Yogesh Kumar |
Maharaja Agrasen Hospital |
Dept of ENT,
West Punjabi Bagh,
New Delhi – 110026.
New Delhi
DELHI |
9798999911
Yogesh07kansal@yahoo.co.in |
| Dr Hanumanth Prasad M |
Mandya Institute of Medical Sciences |
Department of ENT,District Hospital Campus, Mandya-571401
Mandya
KARNATAKA |
9916856058
drmhp@yahoo.com |
| Dr S Ramesh |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Department of ENT,
Srikakulam – 532001.
Andhra Pradesh.
Srikakulam
ANDHRA PRADESH |
9490713477
rimsresearch@gmail.com |
| Dr Narendra Khippal |
S.M.S. Medical College & Hospital |
Dept of ENT, Institute of Respiratory Diseases,
B-2 Shubhash Nagar Shopping Centre, Shanti Nagar, Jaipur-302016, Rajasthan.
Jaipur
RAJASTHAN |
9829017619
drnkhippal@rediffmail.com |
| Dr Amit Keshri |
Sanjay Gandhi Postgraduate Institute of Medical sciences |
Department of Neuro-otology, Raebareli Road, Lucknow 226014, Uttar pradesh
Lucknow
UTTAR PRADESH |
8004904461
amitkeshri2000@yahoo.com |
| Dr Mehrin Shamin |
Sapthagiri Institute Of Medical Science and Research Center |
Dept of Pulmonology, # 15, Chikkasandra, Hesaraghatta Main Road,
Bangalore-560090.
Karnataka.
Bangalore
KARNATAKA |
9900115382
Mehrin.shamim@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Aster AadharEthics Committee |
Approved |
| Down Town Hospital |
Approved |
| Ethics Committee Apex Hospital Private Limited |
Approved |
| Ethics Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Ethics Committee, Apollo Hospital |
Submittted/Under Review |
| Ethics committee, M/s. King George Hospital |
Submittted/Under Review |
| Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Approved |
| Ethics Committee, Sapthagiri Institute Of Medical Science and Research Center |
Submittted/Under Review |
| Ethics Committee, Siddhartha Medical College & Govt. General Hospital |
Submittted/Under Review |
| Institutional Ethics Committe, Mandaya Hospital |
Approved |
| Institutional Ethics committee, Sanjay Gandhi postgraduate Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Christian Medical College and Hospital |
Approved |
| Institutional Ethics Committee, GCS Medical College Hospital & Research Centre, |
Approved |
| Institutional Ethics Committee, Grant Govt. Medical College & Sir J.J. Group of Hospitals |
Approved |
| Institutional Ethics Committee, KRIMS Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Approved |
| KMRF’S Nikop Institutional Ethics Committee |
Approved |
| The Ethics Committee, S.M.S Medical College and Attached Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Allergic Rhinoconjunctivitis, (1) ICD-10 Condition: H108||Other conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilastine Tablet 20 mg |
One Tablet to be taken orally once daily 1 to 2 hours before meal for 28 days |
| Comparator Agent |
Levocetirizine Tablet 5 mg |
One Tablet to be taken orally once daily 1 to 2 hours before meal for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of both genders with age ≥ 18 years and ≤ 65 years.
2. Subjects with total IgE level ≥75kU/L will be included.
3. Subjects with absolute eosinophil count value of 80 cells/ml will be included.
4. All patients will additionally require to have a minimum reflective Total nasal symptom (TNSS) score and Total Non-nasal symptoms (Non – TNSS) of ≥ 72 as sum of the six assessments in the last 3 days of the screening period;
o Total Nasal Symptoms (TNSS): obstruction, rhinorrhoea, itching and sneezing
o Total Non-nasal symptoms (Non -TNSS): ocular itching, lacrimation, itching of ears and/or palate and ocular redness
Each of these symptoms will be assessed over the preceding 12 hours, twice daily, graded on a pre-determined severity scale of 0-3 to Total nasal symptom (TNSS) score and Total Non-nasal symptoms (Non – TNSS).
5. Freshly diagnosed subject will be included in the study.
6. Patients with Acute Bronchial Asthma will be included in the study (Diagnosed by Spirometry).
7. Female patients of child bearing potential those are non-pregnant and willing to use effective contraceptive method during participation in the study. If the subject is not already consuming Oral Contraceptives, they should opt for IUCD.
8. Subject willing to sign informed consent form (ICF) prior to any screening procedure. |
|
| ExclusionCriteria |
| Details |
1. Patients with hypersensitivity to H1.
2. Patients with H2 antihistamines within 3 days of randomization.
3. Patients with systemic or intranasal corticosteroids within 4 weeks
4. Patients with intranasal and systemic decongestants within 3 days of randomization to treatment will be excluded from the study
5. Patients who had received allergen immunotherapy
6. CNS acting agents (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time will be also excluded.
7. Patients who had undergone nasal surgery in the previous 6 months and patients with nasal polyps, large adenoids, significant deviation of the nasal septum, acute or chronic sinusitis, any injury or tumor in the nose.
8. Patients with upper respiratory tract infection.
9. Patients with Chronic/ Perennial Asthma
10. Patients who are currently using beta blockers or corticosteroids
11. Patients with parasite infections (such as tapeworms, roundworms, flatworms and ringworms) [Diagnosed by stool test]
12. Any clinically significant condition (cardiovascular, neurological, hepatic, renal or malignant diseases).
13. History of alcohol abuse and Current smokers.
14. Pregnant or lactating women
15. Patients with Diabetes Mellitus
16. Subjects who have participated in other clinical studies within 3 months
17. Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy
18. Subject with the following clinically significant laboratory abnormalities:
AST, ALT, Serum Bilirubin > 2 x Upper Limit Normal (ULN)
Serum Creatinine, BUN > 2 x Upper Limit Normal (ULN) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg. |
Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. QOL (Quality of Life) assessed by the RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire |
Day 7, Day 14, Day 21 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "254"
Final Enrollment numbers achieved (India)="214" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/06/2017 |
| Date of Study Completion (India) |
10/03/2018 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A Comparative, Two arm, Randomized, Double
blind, Parallel group, Non- Crossover, Multicentric Clinical Study to evaluate
Efficacy, Safety and Tolerability of Bilastine Tablet 20 mg as compared with
Levocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis. Primary objective of this trial is to study the Mean change in TSS (Total
Symptom Score) of Allergic Rhinoconjunctivitis after 28 days. |