FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047227 [Registered on: 11/11/2022] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effects of combination drug in patients suffering from Dry Cough associated with sneezing and running nose or throat irritation.  
Scientific Title of Study   A Multicentric, Phase IV Clinical Trial to Evaluate Safety and Efficacy Of Fixed Dose Combination Of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Sustained Release Suspension in Patients Suffering from Dry Cough Associated with Sneezing and/ or Running Nose and/ or Throat Irritation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICR/20/019 Version No. 1.0 ; Dated 11 Nov 2020   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sapan Kumar Behera 
Designation  Medical Monitor India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited Sun House 201 B 1 Western Express Highway Goregaon Mumbai 400063 Maharashtra India

Mumbai
MAHARASHTRA
400063
India 
Phone  919908344425  
Fax    
Email  sapan.behera@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sapan Kumar Behera 
Designation  Medical Monitor India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited Sun House 201 B 1 Western Express Highway Goregaon Mumbai 400063 Maharashtra India

Mumbai
MAHARASHTRA
400063
India 
Phone  919908344425  
Fax    
Email  sapan.behera@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Mr Abhsihek Srivastava 
Designation  Head Clinical Operations 
Affiliation  Lets Evolve Life Pvt. Ltd.  
Address  707 708 Shivalik Shilp Nr Iskcon Cross Road Ahmedabad Gujarat-380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  9148791825  
Fax    
Email  abhisheksrivastava@letsevolvelife.com  
 
Source of Monetary or Material Support  
Sun Pharma Laboratories Limited 
 
Primary Sponsor  
Name  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited Tandalja Vadodara 90020 Gujarat India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Katiyar  Apollo Specialty Hospital Pvt. Ltd  Ground Floor, OPD room G13 Apollo Specialty Hospital Pvt. Ltd., Ground Floor OPD room 14/138, Chunni Ganj, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 9889888080

skkatiyarin@gmail.com 
Dr Ambanna Gowda  Citizen Hospital  Ground Floor OPD room, Citizen Hospital, #14, 2"d Main, Dispensary Road, Kalasipalya, Bangalore 560002
Bangalore
KARNATAKA 		 9845270377

dr.ambanagowda@gmail.com 
Dr Hemant Gupta  Grant Medical college  OPD 20 Department of medicine Grant Medical college
Mumbai
MAHARASHTRA 		 9870456888

drhemantgupta@hotmail.com 
DrSanket Mathukiya  Hi tech Multispeciality Hospital  OPD room no.4, Ground Floor Sector 3D Plot No 1180 Gh Road Near Gh1 1/2 Bus Stand Gandhinagar Gujarat 382003
Gandhinagar
GUJARAT 		 9952314322

drsanket.mathukiya@gmail.com 
Dr Sanjiv Maheshwari  Jawahar Lal Nehru Medical  Room No 99, OPD building, Jawahar Lal Nehru Medical college Kala Bagh, Ajmer -305001.
Ajmer
RAJASTHAN 		 9460479888

doctor.sanjiv@gmail.com 
Dr Micky Patel  Lotus Multispeciality Hospital  OPD room no. 01, Second Floor Lotus Multispeciality Hospital Block N Krupa Residency Motera stadium road Sabarmati Ahmedabad 380005
Ahmadabad
GUJARAT 		 9909007305

lotushospital.79@gmail.com 
Dr Manish Jain  Maharaja Agrasen Superspeciality Hospital  Room No 9 Basement, Clincial Research Department, , Maharaja Agrasen Superspeciality Hospital Central spine, Agrasen aspatal marg, sector7, Vidyadhar Nagar, Jaipur, Rajasthan. 302039
Jaipur
RAJASTHAN 		 9414414834

doctormanishjain2@gmail.com 
Dr Gangwani Dinesh Kumar  Priyadarshani Nursing Home  201-208, Department of medicine, Priyadarshani Nursing Home, M-Baria Estate, Kargil nagar road, Opp. Manvel Pada, Talav, Virar (East) Dist Palghar
Mumbai
MAHARASHTRA 		 9833527266

drgangwanidinesh@gmail.com 
Dr Rajesh Kumar Padhy   Sparsh Hospital and Critical Care (P),Ltd  OPD room 05, Ground Floor, Sparsh Hospital and Critical Care (P),Ltd Plot No.A/407,Sahid Nagar,Bhubaneswar-751007
Bargarh
ORISSA 		 9437166120

drrajeshpadhy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Institutional Ethics committee New Health Care Nursing Home   Approved 
Intitutional Ethics committee  Submittted/Under Review 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
Intitutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed dose combination of Dextromethorphan Hydrobromide 30 mg SR and Chlorpheniramine Maleate 4 mg SR/5ml Suspension  Children aged 6 to under 12 years 5 mL every 12 hours, not to exceed 10 mL in 24 hours.(Maximum daily dose every 24 hours- Dextromethorphan (60 mg), Chlorpheniramine (12 mg)) Adults and children 12 years of age and over: 10 mL every 12 hours, not to exceed 20 mL in 24 hours (Maximum daily dose every 24 hours: Dextromethorphan (120 mg), Chlorpheniramine (24 mg)) 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient of either gender aged more than or equal to 6 years and ready to give written informed consent/assent to participate in the study at the time of screening
An additional written informed consent will be taken from Parent or legally acceptable representative (as applicable) in case assent is taken from patient aged more than or equal to 6 years and less than 18 years
Patient suffering from dry cough associated with sneezing and/or running nose and or throat irritation
Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control example combined estrogen and progestogen containing [oral, intravaginal, or transdermal]
or progesterone only [oral injectable or implantable] hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system OR bilateral tubal occlusion vasectomized partner or total sexual abstinence) 
 
ExclusionCriteria 
Details  Patient with chronic cough that occurs due to smoking, asthma or COPD or any other reasons

Patient with clinically significant conditions including but not limited to: pulmonary (e.g. bronchitis, bronchiectasis or asthma), central nervous system (e.g. epilepsy), severe hypertension (seated systolic ≥ 180 mmHg, or seated diastolic ≥ 110 mmHg), glaucoma, ocular hypertension (IOP > 21 mmHg), severe hepatic impairment (Child Pugh Class C) and severe renal impairment (eGFR < 15 ml/min)

Patient with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose
Malabsorption

Patient with history of HIV, Hepatitis B and Hepatitis C

Patient used any medication or herbal remedies to treat cold and cough prior to screening (antibiotics in the last 14 days, antitussive or antihistamines or decongestant or herbal remedies in the last 72 hours, medicated lozenge in the last 24 hours)

Patient who have used monoamine oxidase inhibitors within 14 days prior to screening

Patient with a history of allergic response to any of the investigational product and/or its components

Patient with current diagnosis of substance abuse (as per DSM-5) or history of alcohol or drug abuse
in the past 3 months prior to screening visit

Patient who has participated in another investigational study within 30 days prior to screening of this
study or planning to participate during the study

Female patient who is pregnant and /or lactating

Patient judged unfit for this study by investigator

Investigator, study personnel, sponsor representatives and their first degree relatives

Patient operating heavy complex machinery or who intend to drive
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety assessment includes Treatment Emergent Adverse Events (TEAEs) reported during the study
Change in severity of cough as per cough severity score 		 Baseline,Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Change in frequency of cough (recorded since last 24 hours) as per Likert scale
Change in severity of sneezing as per Likert scale
Change in severity of running nose from baseline
Change in severity of throat irritation from baseline  		 Baseline, Day 7 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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 4 
Date of First Enrollment (India)   21/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a single arm, open label, multicenter trial to evaluate safety and efficacy of fixed dose combination of dextromethorphan hydrobromide 30 mg and chlorpheniramine maleate sustained release 4mg/5ml suspension. Patients suffering from dry cough which is associated with sneezing and/ or running nose and/ or throat irritation will be given this combination of drug twice daily for 7 days. Total number of patients in this trail are 230. This study will be conducted in 10 sites in India. The primary outcome will be of safety assessment including treatment emergent adverse events reported during the study, co- primary outcome will be change in severity of cough as per cough severity score from baseline. Secondary outcome will be evaluated as follows: change in frequency of cough, change in severity of sneezing, change in severity of running nose, change in severity of throat irritation. 


 
Close