| CTRI Number |
CTRI/2023/09/057263 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of FDC syrup of Bilastine/Dextromethorphan/ Phenylephrine in patients with cough with common cold or allergy. |
|
Scientific Title of Study
|
Multi-center, randomized, parallel group, active-controlled, open label clinical trial to evaluate efficacy and safety of fixed dose combination syrup of Bilastine 3.3 mg, Dextromethorphan 10 mg and Phenylephrine 5 mg per 5 mL, in patients with cough associated with common cold or allergy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPL/CT/2022/001/III; Version 2.0 Dated: 12-May 2022. |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Kodgule |
| Designation |
Sr.GM-Clinical Development Branded Generics |
| Affiliation |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
District: Mumbai
State: Maharashtra
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912240189999 |
| Fax |
|
| Email |
Rahul.Kodgule@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Amol Pendse |
| Designation |
GM-Clinical Research Operations |
| Affiliation |
Glenmark Pharmaceuticals Ltd |
| Address |
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
District: Thane
State: Maharashtra
Thane
MAHARASHTRA
400709
India |
| Phone |
912267720000 |
| Fax |
|
| Email |
Amol.Pendse@glenmarkpharma.com |
|
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Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd.
M/s Glenmark Pharmaceuticals Ltd., Glenmark House, B2, Mahalaxmi Chambers 22, BhulaBhai Desai Road, Mumbai-400026 |
|
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Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
M/s Glenmark Pharmaceuticals Ltd., Glenmark House, B2, Mahalaxmi Chambers 22, BhulaBhai Desai Road, Mumbai-400026 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ganesh Natthuji Dakhale |
All India Institute of Medical Sciences |
Department of Pharmacology,
All India Institute of Medical Sciences,
Plot No. 2, Sector-20, MIHAN,
Nagpur-441108
Nagpur
MAHARASHTRA |
9850539353
gndakhle@rediffmail.com |
| Dr Agrawal Atulram Ashokkumar |
Assured Care Plus Hospital |
4th and 5th floor Star Plus Complex, Lam Road, Near Muktidham Temple, Opp. NMC Divisional Office, Nashik Road, Nashik-422101
Nashik
MAHARASHTRA |
918698324324
dratulacph@gmail.com |
| Dr Ashish Tulshiram Nikhare |
Lata Mangeshkar Multispeciality Hospital |
YMCA Complex, Maharajbagh Road, Sitabuldi, Nagpur-440012
Nagpur
MAHARASHTRA |
8149927258
ashoonikh@gmail.com |
| Dr Shivnitwar Sachin Kisan |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057
Pune
MAHARASHTRA |
9730475068
sachinshivnitwar94@gmail.com |
| Dr Sandeep Kumar Gupta |
M. V. Hospital and Research Centre |
314/30 , Mirza Mandi Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
919336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Magar Pankaj Kondiram |
Pulse Multispeciality Hospital |
Vishwa Arcade Opp.Deccan Pavilion Hotel, Mumbai-Banglore Highway, Narhe, Pune - 411041
Pune
MAHARASHTRA |
9970126406
drpankajmagar@gmail.com |
| Dr Pedditi Raghavendra Reddy |
Renova Neelima Hospitals |
Department of Clinical Research,
2d Floor, B-Block, Czech, Colony 7-2-1736, Sanath Nagar Main Rd,
Sanath Nagar, Hyderabad-500034
Hyderabad
TELANGANA |
917799992266
drraghavendrareddy.p@gmail.com |
| Dr Patil Sandesh Sahebarao |
Sri Siddhivinayak Maternity and Nursing Home |
Unity Campus, Opp. KTHM College, Gangapur Road,
Nashik - 422002
Nashik
MAHARASHTRA |
9892503486
drsandeshpatil@gmail.com |
| Dr Rudra Prasad Sahu |
Suyash Hospital |
Gudhiyari Road, near Avinash lifestyle tower, behind Hotel Piccadily, Kota, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH |
918874395575
sahudr.rudra@yahoo.com |
| Dr Aravind GN |
Victoria Hospital, Bangalore Medical College and Research Institute |
Mysore Road, near City Market, New Tharagupet, Banglore, Karnataka-560002
Bangalore
KARNATAKA |
919901911009
draravind80@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| "Institutional Ethics Committee- Neelima Hospitals" |
Approved |
| "Suyash Hospital Institutional Ethics Committee" |
Approved |
| Ethics Committee of BMCRI |
Approved |
| Ethics Committee of Pulse Multispecialty Hospital |
Approved |
| IEC, AIIMS Nagpur |
Approved |
| Institutional Ethics Committee - Assured Care Plus Hospital |
Approved |
| Institutional Ethics Committee - Lata Mangeshkar Multispeciality Hospital |
Approved |
| Institutional Ethis Committee for MV Hospital and Research Centre |
Approved |
| LPR Ethics Committee |
Approved |
| Shree Siddhivinayak Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC OF Bilastine 3.3 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg per 5 mL |
Dosage Form: Syrup
Dose: A single dose will consist of 10 mL of syrup
Dosage Frequency: Thrice daily
Mode of Administration: Oral
Duration of treatment: 7 days |
| Comparator Agent |
FDC OF Chlorpheniramine maleate 2 mg, Dextromethorphan HBr 10 mg and Phenylephrine HCl 5 mg per 5 mL [Alex® (SF)] |
Dosage Form: Syrup
Dose: A single dose will consist of 10 mL of syrup
Dosage Frequency: Thrice daily
Mode of Administration: Oral
Duration of treatment: 7 days |
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age at least 12 years (completed) and less than 65 years (subjects who completed 65th birthday will be excluded) at the time of signing consent/assent.
2. Provided written informed consent (pediatric assent and parental consent in case of children < 18 years of age).
3. Male or female subjects with acute cough of less than 7 days duration at the time of consent, associated with common cold or allergy.
4. Cough severity at least 60 mm on visual analogue scale (VAS) at screening.
5. Willing and able to comply with all aspects of the protocol.
6. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pre-treatment urine pregnancy test
7. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
|
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| ExclusionCriteria |
| Details |
1.A productive cough with excessive secretions, regardless of colour.
2.Subjects with chronic cough (i.e. history of chronic bronchitis in smokers, gastroâ€esophageal reflux, asthma, hyperâ€responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumor, tuberculosis or fungal infections).
3.Subjects receiving oral or intranasal anti-histamine or cough suppressant or decongestant within 7 days prior to screening.
4.Subjects taking angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) within 14 days of consent
5.Pregnant or breastfeeding.
6.Positive urine pregnancy test at screening.
7.Known hypersensitivity to the study drugs (investigational product or comparator) or any of the excipients.
8.Subjects with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study.
9.Previous participation in another interventional clinical study within 30 days of first dose in this study.
10.Concurrent enrolment in another interventional clinical study.
11.Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
12.Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
13.Subjects with history of significant cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement or phaeochromocytoma at screening.
14. Subjects receiving monoamine oxidase inhibitor, a selective serotonin reuptake inhibitor, or other medications for depression, psychiatric, or emotional conditions, or Parkinson s disease with within 14 days prior to consent. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to Day 4 in cough severity on a 100 mm Visual Analogue Scale (VAS) |
From baseline to Day 4 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Drowsiness score on Profile of Mood State (POMS) questionnaire |
From Baseline to end of study |
| Change from baseline to Day 8 in cough severity on a 100 mm VAS |
From baseline to Day 8 |
| Proportion of subjects with resolution of cough symptoms on Day 4 and 8 |
On Day 4 and Day 8 |
| Proportion of subjects with complete clinical cure on Day 4 and 8 |
On Day 4 and Day 8 |
| Patient Global Impression of Change (PGIC) on Day 4 and 8 |
On Day 4 and Day 8 |
| Investigator Global Impression of Change (IGIC) on Day 4 and 8 |
On Day 4 and Day 8 |
| Change from baseline to Day 4 and 8 in cough frequency on a 100 mm VAS |
From Baseline to Day 4 and Day 8 |
| Change from baseline to Day 4and 8 in sleep deprivation on a 100 mm VAS |
From Baseline to Day 4 and Day 8 |
| Adverse events |
From the start to end of study |
|
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Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
Final Enrollment numbers achieved (Total)= "134"
Final Enrollment numbers achieved (India)="134" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| Date of Study Completion (India) |
04/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This
is a Multi-center, randomized, parallel group, active-controlled, open label
clinical trial to evaluate efficacy and safety of fixed dose combination syrup
of Bilastine 3.3 mg, Dextromethorphan 10 mg and Phenylephrine 5 mg per 5 mL, in
patients with cough associated with common cold or allergy
The
maximum total duration of study is of 8 days which consisted of 7 treatment
days.
The primary outcome
measures consist of change from baseline in cough severity on 100mm VAS at
Day 4. |