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CTRI Number  CTRI/2024/04/065184 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two paracetamol formulations for the taste and effectiveness in children with fever 
Scientific Title of Study   A Taste and Efficacy Comparison of Two Paracetamol Preparations for the Treatment of Fever in Children 
Trial Acronym  Fever - TEC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anurag Agarwal 
Designation  Professor 
Affiliation  Maulana Azad Medical College and Associated Lok Nayak Hospital 
Address  Department of Pediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital Bahadur Shah Zafar Marg New Delhi India

New Delhi
DELHI
110002
India 
Phone    
Fax    
Email  doctoranuragagarwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harsh Chaturvedi 
Designation  Associate Vice President - Medical Affairs 
Affiliation  Pulse Pharmaceuticals Pvt. Ltd 
Address  Plot No 18/1 Sector III HUDA Techno Enclave HITEC City Hyderabad Telangana 500081

Hyderabad
TELANGANA
500081
India 
Phone  9100956190  
Fax    
Email  harsh@pulsepharma.net  
 
Details of Contact Person
Public Query  
Name  Dr Harsh Chaturvedi 
Designation  Associate Vice President - Medical Affairs 
Affiliation  Pulse Pharmaceuticals Pvt. Ltd 
Address  Plot No 18/1 Sector III HUDA Techno Enclave HITEC City Hyderabad Telangana 500081

Hyderabad
TELANGANA
500081
India 
Phone  9100956190  
Fax    
Email  harsh@pulsepharma.net  
 
Source of Monetary or Material Support  
Pulse Pharmaceuticals Pvt. Ltd. 
 
Primary Sponsor  
Name  Pulse Pharmaceuticals Pvt. Ltd. 
Address  Plot No. 18/1, Sector-III, HUDA Techno Enclave, HITEC City, Hyderabad, Telangana 500081 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anurag Agarwal  Maulana Azad Medical College and Associated Hospital  Ward no. 19, Department of Pediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital Bahadur Shah Zafar Marg New Delhi 110 002
New Delhi
DELHI 		 9968604259

doctoranuragagarwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Marketed Paracetamol Paediatric Oral Suspension 120mg/5ml  24 hours 
Intervention  NEXPAR (Paracetamol Oral Solution (Taste Masked) 125 mg/5ml}  24 hours 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  i. Male and female subjects from the age of ≥3 years to 12 years (both inclusive) are eligible to participate in the study.
ii. Only participants requiring treatment on an outpatient basis will be recruited.
iii. The body temperature should be at least 38.5°C/ 101.3°F, with an upper boundary of 40°C/ 104°F associated with various pathologies such as sore throat, influenza, respiratory tract infection, ear infection or immunization.
iv. Parents of all patients will provide signed Informed Consent and patients in the age group of 7-12 will give their own consent along with that of their parents’. 
 
ExclusionCriteria 
Details  i. Hypersensitivity to any of the study drug constituents.
ii. A history of any condition that interfered with the absorption, distribution, metabolism or excretion of the study drug.
iii. Patients with hepatic failure.
iv. Patients with previous history of febrile convulsions.
v. Patients, who had received treatment with an antipyretic drug up to 6 hours before inclusion, or treatment with antibiotic therapy in the 12 hours before the start of the trial, are also excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare reduction in fever after administration of two different formulations from baseline at 30 minutes 1 2 3 4 5 6 8 12 and 24 hours post-dosing
To evaluate the taste acceptability of two different formulations by the child or childs parents or the minder, measured using a Hedonic Rating Scale
To Document any adverse events occurring during the course of the study. 		 baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To document need for an additional dose or rescue medication  baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours  
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) 20/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  
Study Title: A Taste and Efficacy Comparison of Two Paracetamol Preparations for the Treatment of Fever in Children.
Study Design: Open label, randomized, double arm, comparative, single centre.
 
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