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CTRI Number  CTRI/2025/12/098995 [Registered on: 12/12/2025] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study of Paracetamol Tablets in Adults with Acute Febrile or Febrile-Pain Conditions 
Scientific Title of Study   An Open-Label, Multicenter, Randomized, Parallel, Four-Arm, Interventional Study to Compare the Rapid Antipyretic and Analgesic Efficacy and Safety of Paracetamol Tablets in Adults with Acute Febrile or Febrile-Pain Conditions (THE FAST STUDY) 
Trial Acronym  THE FAST STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/FST/25-012 Version 1.0 Dated 12 Nov 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amitrajit Pal 
Designation  Medical Advisor 
Affiliation  Alkem Laboratories Ltd. 
Address  Alkem Laboratories Ltd., Alkem House, Lower Parel, Mumbai - 400 013

Mumbai
MAHARASHTRA
400013
India 
Phone  8335012814  
Fax    
Email  amitrajit.pal@alkem.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amitrajit Pal 
Designation  Medical Advisor 
Affiliation  Alkem Laboratories Ltd. 
Address  Alkem Laboratories Ltd., Alkem House, Lower Parel, Mumbai - 400 013


MAHARASHTRA
400013
India 
Phone  8335012814  
Fax    
Email  amitrajit.pal@alkem.com  
 
Details of Contact Person
Public Query  
Name  Dr Amitrajit Pal 
Designation  Medical Advisor 
Affiliation  Alkem Laboratories Ltd. 
Address  Alkem Laboratories Ltd., Alkem House, Lower Parel, Mumbai - 400 013


MAHARASHTRA
400013
India 
Phone  8335012814  
Fax    
Email  amitrajit.pal@alkem.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Ltd., Alkem House, Lower Parel, Mumbai - 400 013 
 
Primary Sponsor  
Name  Alkem Laboratories Ltd. 
Address  Alkem House, Lower Parel, Mumbai - 400 013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok V   Dr. Ashoks Clinic, Bengaluru  Department of General Medicine, Dr. Ashoks Clinic, Bengaluru,No. 169/18, Ground Floor, 1st Main, Vidyaranya Nagar, Magadi Road, Bengaluru
Bangalore
KARNATAKA 		 9845129828

drashokvb@gmal.com 
Dr Amar Raykantiwar  Atharva Diabetes and Weight Loss Center  Department of General Medicine, Atharva Diabetes and Weight Loss Center, B-BUILDING, Dhayari Phata chowk , First floor , Siddharth complex, above Manik mobile shopee, Pune, Maharashtra 411068
Pune
MAHARASHTRA 		 8451941050

dr.rai27@gmail.com 
Dr K R Shivaprasad  Dooravani Diagnostics and Multispeciality Clinic  Department of General Medicine, Dooravani Diagnostics and Multispeciality Clinic, Ramamurthynagar, Dooravani Nagar, Bengaluru, Karnataka 560016, India.
Bangalore
KARNATAKA 		 9900706401

kambannashivaprasad@gmail.com 
Dr Suhas N Kalashetti  Shree Samarth Hospital  Department of General Medicine, Shree Samarth Hospital, 227, Omkar Apartment, Karande Chowk, Rasta Peth, Pune-411011
Pune
MAHARASHTRA 		 8805387387

skalashetti@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Submittted/Under Review 
ACE Independent Ethics Committee  Submittted/Under Review 
Central Independent Ethics Committee  Approved 
Central Independent EthicsCommittee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R509||Fever, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calpol 650 tablet Dose: 650 mg(1 tablet), Frequency: Once (single dose), Route of administration: Oral Duration: Once for one day  Route/mode of administration: Oral, with water Dose: 1 tablet Frequency: Once (single dose)  
Comparator Agent  Dolo-650® tablet Dose: 650 mg(1 tablet), Frequency: Once (single dose), Route of administration: Oral, Duration: Once for one day  Route/mode of administration: Oral, with water Dose: 1 tablet Frequency: Once (single dose)  
Comparator Agent  Paracetamol Tablets IP 650 mg Dose: 650 mg(1 tablet), Frequency: Once (single dose), Route of administration: Oral Duration: Once for one day  Route/mode of administration: Oral, with water Dose: 1 tablet Frequency: Once (single dose) 
Intervention  SUMO-L™ Fast 650 tablet Dose: 650 mg(1 tablet), Frequency: Once (single dose), Route of administration: Oral Duration: Once for one day   Route/mode of administration: Oral, with water Dose: 1 tablet Frequency: Once (single dose)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male or female aged 18 to 60 years (both inclusive)
2. Body temperature (oral) greater than equal to 38 degree celsius (greater than equal to 100.4degree Fahrenheit), with or without associated pain
3. Symptom onset within 72 hours preceding screening
4. Willingness to provide written informed consent 
 
ExclusionCriteria 
Details  1. Known allergy/ hypersensitivity/ contraindications to paracetamol/acetaminophen
2. Fever/pain caused due to chronic clinical conditions (e.g., osteoarthritis, tuberculosis, malignancy, etc.)
3. Known liver dysfunction, defined as raised alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or levels of ALT/ AST greater than 2 times the upper limit of normal (ULN) based on lab reports within 1 month prior to screening or as per Investigators judgement
4. Use of any antipyretic or analgesic within 12 hours prior to screening
5. Requirement of hospitalization at baseline
6. Pregnant or lactating women
7. Refusal or inability to comply with the requirements of the protocol for any reason, including stay at study site for data accrual till 90±2 min post single dose administration and answering questionnaires
8. Any other condition(s) in the individual which, in the opinion of the Investigator, could confound the results of the trial, put the patient at undue risk, or make the patient unsuitable for participation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in body temperature (oral)
2. Rate of fall of baseline body temperature (defined as decrease in temperature per minute)
3. Time to greater than equal to 1°C reduction in baseline body temperature (oral) 		 1.baseline, 10, 15, 20, 30, 45, 60, and 90 min
2. Baseline to 90 min
3. Baseline to 90 min 
 
Secondary Outcome  
Outcome  TimePoints 
Change in pain score based on the NRS scale  baseline, 10, 15, 20, 30, 45, 60, and 90 min 
Rate of decrease of baseline pain score (defined as decrease in pain score per minute)  Baseline to 90 min 
Time to greater than equal to 30% reduction in baseline NRS score  Baseline to 90 min 
Time to fever resolution (defined as body temperature less than equal to 37°C or less than equal to 98.6°F)  Baseline to 90 min 
Proportion of patients achieving complete fever resolution (less than equal to 37°C or less than equal to 98.6°F) at 90 min  90 min 
Proportion of patients with greater than equal to 30% reduction in baseline NRS score  10, 15, 20, 30, 45, 60, and 90 min 
Time to pain resolution (defined as NRS score of 0)  Baseline to 90 min 
Proportion of patients achieving complete pain resolution (defined as attainment of NRS score of 0)   90 min 
Proportion of patients with treatment satisfaction for resolution of febrile or febrile-pain conditions (based on a 5-point Likert scale: 1=very unsatisfied,
2=unsatisfied
3=neutral,
4=satisfied,
5=very satisfied) 		 90 min 
Proportion of participants with AEs and SAEs  Baseline to 90 min 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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   N/A 
Date of First Enrollment (India)   22/12/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   After obtaining written approval from the Ethics Committees, eligible febrile adult male and female patients presenting with/ without associated pain will be enrolled. Details such as demographic data, medical history/comorbidities, and prior medications will be recorded at baseline before treatment. Vital signs including blood pressure, pulse rate, and respiratory rate will be recorded. Body temperature (oral) will be measured using a calibrated digital thermometer and noted. Participants will be asked to record their pain on the NRS scale. All eligible participants will receive a single dose of one of the four study medications (SUMO-L™ Fast 650, Dolo-650®, Calpol 650, and Paracetamol Tablets IP 650 mg (unbranded/generic label)) depending on randomization. Participants will thereafter be monitored in-person over the next 90±2 min. Recording of temperature and pain score will be done at 10±2, 15±2, 20±2, 30±2, 45±2, 60±2, and 90±2 min after single dose administration of study medication. Patient satisfaction will be recorded at 90±2 min based on resolution of febrile or febrile-pain conditions. AEs and SAEs will be recorded throughout study participation. 
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