| CTRI Number |
CTRI/2021/10/037217 [Registered on: 08/10/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A post marketing surveillance study to monitor the safety and efficacy of Codeine phosphate and Chlorpheniramine maleate for management of symptoms of dry cough in adult patients. |
|
Scientific Title of Study
|
AN OBSERVATIONAL, PRESCRIBER BASED, MULTICENTRIC,
POST MARKETING SURVEILLANCE STUDY (PMS) TO GENERATE
SAFETY & EFFICACY DATA OF FIXED DOSE COMBINATION
(FDC) OF CODEINE PHOSPHATE 10mg & CHLORPHENIRAMINE
MALEATE 4mg PER 5ml ORAL SYRUP FOR MANAGEMENT OF
SYMPTOMS OF DRY COUGH IN ADULT PATIENTS.
|
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ICS/LAB/2021-004 Version 2.0 Date 19 OCT 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R M Chhabra |
| Designation |
Medical Monitor/Trial Coordinator |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd., Room # 512, Clincal Trial Division, Clinical Operations Department , Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India.
Insignia Clinical Services Pvt. Ltd. Room # 512, Clincal Trial Division, Clinical Operations Department , Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India.
North West
DELHI
110034
India |
| Phone |
011-49049115 |
| Fax |
011-49049115 |
| Email |
Chhabradrrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R M Chhabra |
| Designation |
Medical Monitor/Trial Coordinator |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clincal Trial Division, Clinical Operations Department , Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India.
Insignia Clinical Services Pvt. Ltd. Room # 512, Clincal Trial Division, Clinical Operations Department , Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India.
North West
DELHI
110034
India |
| Phone |
011-49049115 |
| Fax |
011-49049115 |
| Email |
Chhabradrrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R M Chhabra |
| Designation |
Medical Monitor/Trial Coordinator |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clincal Trial Division, Clinical Operations Department , Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India.
Insignia Clinical Services Pvt. Ltd. Room # 512, Clincal Trial Division, Clinical Operations Department , Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India.
North West
DELHI
110034
India |
| Phone |
011-49049115 |
| Fax |
011-49049115 |
| Email |
Chhabradrrm@gmail.com |
|
|
Source of Monetary or Material Support
|
| LABORATE Pharmaceuticals India Limited, E-11 Industrial Area Panipat 132103 Haryana |
|
|
Primary Sponsor
|
| Name |
LABORATE Pharmaceuticals India Limited |
| Address |
E-11 Industrial Area Panipat 132103 Haryana |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| LABORATE Pharmaceuticals India Limited |
E-11 Industrial Area Panipat 132103 Haryana |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Gopal Rao |
Government Medical College and Government General Hospital (Old RIMSGGH) |
Research Wing 2nd Floor Department of Medicine, Government Medical College and Government General Hospital (Old RIMSGGH), Srikakulam, Andhra Pradesh- 532001
Srikakulam
ANDHRA PRADESH |
9912320517
muralidhargudla@yahoo.com |
| Dr Ram Babu |
Jaipur Golden Hospital |
Room NO. 04, Clinical Trial Division, Medicine Dept., 02, Institutional Area, Sector III, Rohini, Delhi 110085
North West
DELHI |
011-27907000
011-27907000
JGHDSMO@GMAIL.COM |
| Dr Pathak Niranjan Pandurang |
PCMCs PGI Yashwantrao Chavan Memorial Hospital |
2nd Floor General Medicine Department PCMCs PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
7057582759
drpratiksunservices@gmail.com |
| Dr Ashok Kumar |
Santosh Medical College & Hospital |
3rd Floor, Clinical Trial Division, No 1, Ambedkar Road, Ghaziabad 201001
Ghaziabad
UTTAR PRADESH |
1204666650
smchgzb@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt. Medical College Govt. General Hospital |
Approved |
| Institutional Ethics Committee-Yashwantrao Chavan Memorial Hospital |
Approved |
| Society for Academic Scientific Translational Research Advancement Ethics Committee |
Approved |
| Society for Academic Scientific Translational Research Advancement Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Codeine Phosphate 10mg and Chlorpheniramine Maleate 4mg |
Codeine Phosphate 10mg and Chlorpheniramine Maleate 4mg per 5 ml syrup two times daily for 7 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized
or practicing a reliable method of birth control during the duration of study)
Subjects with age ranging from 18 to 65 years (both inclusive).
2. Subjects having dry cough (less than 7 days) of any origin and may be with related
symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if
present) (absence of bronchial mucus/phlegm production).
3. Not under any antibacterial or antiviral treatment before recruitment.
4. Subjects ready to abstain from using any drug (which will affect the study
outcome) other than Investigational Product for the treatment of the study condition
during the study period (except in cases when patient’s condition worsens as per
study physician. In this case, Study physician will decide to prescribe antibiotic, if
required).
5. Ready to abstain from the administration of any herbal or ayurvedic treatment or
gargles directed to ease coughing or throat parameters.
6. Willing to provide written informed consent
7. Willing and able to understand and comply with all study requirements |
|
| ExclusionCriteria |
| Details |
1. Subjects with known allergy or hypersensitivity to Codeine Phosphate or
Chlorpheniramine Maleate or any of its components.
2. Subjects who had taken any medicated confectionary, throat pastille, spray or any
product with demulcent properties, any cough medicines or drugs containing
antihistamines within last 24 hours prior to screening.
3. Subjects taking medications with known cough promoting side effects (e.g.,
angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that
in the opinion of the investigator are causing symptoms of cough.
4. Subjects with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic
rhinitis, as well as heart disease.
5. Severe cough requiring hospitalization
6. Subjects who had used any local anesthetic within the past 24 hours.
7. Subjects who have used a longer acting or slow release analgesic during the
previous 24 hours.
8. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse,
or serious neurological or psychological disease
9. Any other condition, which in the opinion of the clinician/investigator, could
interfere significantly with the treatment and assessment process
10. Use of any investigational therapy within 30 days prior to randomization |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Adverse Events, Serious Adverse Events, Unexpected Adverse Events, Adverse Drug Reactions and Treatment Emergent Adverse Events.
|
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the cough severity( daily) and frequency (daily) score assessed during
follow-up visit at Day 3 and Day 7 or up to complete recovery (whichever is
earlier) compared to the baseline. |
Day 3 and Day 7 |
| Number of awakenings in the night due to cough (24 hours) assessed during follow-up visit |
Day 7 |
| Time taken for complete cough relief (days) assessed during follow-up visit |
Day 7 |
| Change in score of throat pain and throat irritation |
Day 7 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/10/2021 |
| Date of Study Completion (India) |
11/03/2022 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, single arm, multi-center, open-label, prescriber based, observational Post Market Surveillance study in Indian adult subjects who have symptoms of cough associated with upper respiratory allergies or common cold aged 18 years or older. The current study will aim to evaluate the safety and efficacy of fixed dose combination of Codeine Phosphate 10mg & Chlorpheniramine Maleate 4mg per 5ml oral syrup in the actual field conditions for the management of symptoms of cough associated with upper respiratory allergies or common cold. The duration of individual participation will be approximately 7 days (7 days treatment period). Key safety assessments include : Adverse Events (AEs), Serious Adverse Events (SAEs), Unexpected Adverse Events, Adverse Drug Reactions. Key efficacy assessments include : Change in the cough severity (daily) and frequency (daily) score assessed during follow-up visit at Day 3 and Day 7 or up to complete recovery (whichever is earlier) compared to the baseline, Number of awakenings in the night due to cough (24 hours) assessed during follow-up visit, Time taken for complete cough relief (days) assessed during follow-up visit, Change in score of throat pain and throat irritation. |