| CTRI Number |
CTRI/2024/12/078427 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Clinico-Epidemiological Profile and Effectiveness Of Codeine Phosphate 10 Mg + Triprolidine Hcl 1.25 Mg, Syrup In Patients With Dry Cough |
|
Scientific Title of Study
|
A Prospective, Single-Arm, Multi-Centric, Open-Label, Post-Market Observational Surveillance (PMOS) Study To Evaluate The Clinico-Epidemiological Profile And Effectiveness Of A Fixed-Dose Combination (FDC) Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup For The Symptomatic Management Of Dry Cough In Patients Not Responding To Non-Opioid Based Antitussives |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Talwar |
| Designation |
Chairman and HOD |
| Affiliation |
Metro Multispeciality Hospital |
| Address |
Room No 501,
Department of Pulmonology, Respiratory and Sleep Medicine,
Metro Multispecialty Hospital
L-94, Sector 11, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9599884572 |
| Fax |
|
| Email |
dtlung@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartik Peethambran |
| Designation |
Associate Director - Medical Affairs |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
Floor 18, Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250462305 |
| Fax |
|
| Email |
kartik.peethambaran@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director Clinical Development & Operation |
| Affiliation |
Abbott Healthcare Private Limited, |
| Address |
Floor 18, Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250460456 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Private Limited,
Floor 18, Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Private Limited |
| Address |
Floor 18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East, Mumbai-400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Balamurugan |
Chest and Diabetes Research Institute |
Department of Pulmonary Medicine, Room No. 105,
Chest and Diabetes Research Institute
2, First Cross Street, Janaki Nagar Extension, Valasaravakkam, Chennai 600087, Tamil Nadu.
Chennai
TAMIL NADU |
9600002646
dr.s.bala@gmail.com |
| Dr Sushant Muley |
Dr Dande Hospitals |
45 A, Hill Road, Gokulpeth Nagpur
Nagpur
MAHARASHTRA |
9923203043
muleysushant85@gmail.com |
| Dr Rajveer Kuldeep |
Jawahar Lal Nehru Medical College |
Room number 6, Department of Respiratory Medicine, JLN Medical College, Kala Bagh, Ajmer,305001, Rajasthan, India
Ajmer
RAJASTHAN |
8949035064
Clinical.jln@gmail.com |
| Dr Ankit Kumar |
King George Medical University |
Room number 201,
Department of Respiratory Medicine KGMU, Shahmeena Road,
Chowk, Lucknow,
Uttar Pradesh, INDIA - 226003
Lucknow
UTTAR PRADESH |
9305015816
ankyar007@gmail.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Hospital |
Room number 101, Department of Respiratory Medicine,
Maharaja Agrasen Hospital, Sector- 7, Central Spine, Vidyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Deepak Talwar |
Metro Hospitals and Heart Institute |
Third Floor,
Metro Center For Respiratory Disease,
Metro Hospitals and Heart Institute,
L-94, Sector 11, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9599884572
dtlung@gmail.com |
| Dr Gajendra Vikram Singh |
Sarojini Naidu Medical College |
Room number101, Department of Respiratory Medicine,
Sarojini Naidu Medical College,
Central Library, Moti Katra, Mantola, Agra, Uttar Pradesh 282003
Agra
UTTAR PRADESH |
9634660312
drsinghgv@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Genebandhu Independent Ethics Committee |
Approved |
| Institutional ethics committee ,Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee, JLN Medical College, Ajmer |
Approved |
| Institutional Ethics Committee, King George Medical University |
Approved |
| Institutional Ethics Committee, S N Medical College, Agra |
Approved |
| Niramay Ethics Committee |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup |
In this study patients will be prescribed 10ml Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup, TID, for a period of 7 days. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both sexes greater than18 years of age.
2. Patients diagnosed with dry cough for at least 1 week and not responding to non-opioid-based antitussives.
3. Patients prescribed codeine phosphate and triprolidine combination for symptomatic relief of dry cough.
4. Dry cough associated with any etiology, as per the discretion of the treating physician and in accordance with the prescribing information.
5. Patients willing and able to comply with the study procedures and sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients in whom Codeine phosphate and Triprolidine HCL are contraindicated.
2. Patients with a known history of hypersensitivity or idiosyncratic reaction to any ingredients of the product.
3. Patients having respiratory depression, COPD, Asthma attack.
4. Patients having alcohol intoxication, Narrow-angle glaucoma, Urinary retention, raised intracranial tension, Head injury.
5. Patients having peptic ulcer, Paralytic ileus, Intestinal Obstruction, Biliary or gall bladder problem.
6. Patients having severe hypertension, severe coronary artery disease.
7. Patients having severe hepatic or renal diseases, Mono Aminase Oxidase Inhibitor (MAOI) therapy or for 2 weeks after stopping MAOI therapy, known CYP2D6 ultra-rapid metabolizers Pregnant or breast-feeding women, Newborn or premature infants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinico-epidemiological profile of patients presenting with dry cough. |
Day 1 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness
1. To evaluate the effectiveness of codeine
2. To evaluate the quality of life (QoL) of patients
Safety
1. To evaluate the safety and tolerability of treatment |
Day 1 and 7 |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/01/2025 |
| Date of Study Completion (India) |
05/06/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
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, multicenter, single-arm, open-label, Post-Market Observational Surveillance (PMOS) Study designed to evaluate the effectiveness and safety of FDC of codeine phosphate 10 mg + Triprolidine HCl 1.25 mg per 5ml oral syrup in the management of dry cough. This multicenter study will enroll 250 adult patients with dry cough, not responding to non-opioid-based antitussives. The patients will be followed up for 7 (± 2) days after enrollment into the study. |