| CTRI Number |
CTRI/2023/10/058936 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
An observational study to determine safety and efficacy of Nimesulide versus available treatment for fever and pain management. |
|
Scientific Title of Study
|
Prospective real world study comparing the safety and effectiveness of Nimesulide with available anti-pyretic and analgesics for treatment of fever or fever with pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-036-FEVE/2023, Version No. 1.0, 11 August 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Rathod |
| Designation |
Head - Clinical Research |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
rahul.rathod@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritwik Banerjee |
| Designation |
Medical Expert |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
9748625278 |
| Fax |
|
| Email |
ritwikbanerjee@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Rajak |
| Designation |
Chief Executive Officer |
| Affiliation |
Innvocept Global Solutions Private Limited |
| Address |
B 7/1 Kothari Compound 27 Acres Nr Tiku-ji-ni Wadi Resort Chitalsar Manapada Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
07680074619 |
| Fax |
|
| Email |
manish.rajak@innvoceptsolutions.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy’s Laboratories Ltd
8-2-337, Road No. 3, Banjara Hills,
Hyderabad 500034, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Reddy’s Laboratories Ltd |
| Address |
8-2-337, Road No. 3, Banjara Hills, Hyderabad 500034, Telangana, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Syed Mustafa Ashraf |
Dr. Mustafas clinic, Hyderabad |
Department of Internal Medicine
H No 12 2 709 C 76 Padmanabhanagar Rethibowli Hyderabad 500028 Telangana India
Hyderabad
TELANGANA |
91-9177629541
asrarhoo@gmail.com |
| Dr R S Raman |
Maharaja Agrasen Hospital |
Department of Medicine
Maharaja Agrasen Hospital West Punjabi Bagh New Delhi 110026 India
New Delhi
DELHI |
91-9312702643
dr.rs.raman.2005@gmail.com |
| Dr Vivek Shejole |
Medipoint Hospitals, Pune |
Research Department
241 1 New D P Road Aundh Pune 411007 Maharashtra India
Pune
MAHARASHTRA |
91-9890847636
drvivek.medipoint@gmail.com |
| Dr Ambrish C |
Medstar Multispeciality Hospital |
Research Department
641 17 1 3 Kodigehalli Main Road Sahakarnagar Bangalore 560092 Karnataka India
Bangalore
KARNATAKA |
91-9845895911
drambrishmedstar@gmail.com |
| Dr Sahebrao Toke |
Ojas Multispeciality Hospital |
Sr No 203 1 Bhondave Chowk D Y Patil College Road Ravet Pune 412101 Maharashtra India
Pune
MAHARASHTRA |
91-9503553685
dr.sahebrao@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maharaja Agrasen Hospital |
Submittted/Under Review |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Ojas Multispeciality Hospital Ethics Committee |
Approved |
| Penta-Med Ethics Committee |
Approved |
| S2J Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ibuprofen (400mg) plus paracetamol (325mg) and Paracetamol (650mg) |
Ibuprofen (400mg) plus paracetamol (325mg) and Paracetamol (650mg).
Route of administration is Oral.
Dose frequency as per investigator’s discretion. |
| Intervention |
Nimesulide Tablets BP 100mg |
Nimesulide Tablets BP 100mg, (Nise®, Dr. Reddy’s Laboratories Ltd).
Route of administration is Oral.
Dose frequency as per investigator’s discretion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Male and female patients of age between 18 to 60 years (both inclusive) and who have been recommended either Nimesulide or Ibuprofen plus Paracetamol or Paracetamol alone during their routine clinic visit at the discretion of the investigator.
- Patients who are able to understand written and or verbal instructions and are ready to comply with all study requirements with a willingness to participate and ready to give written informed consent voluntarily. |
|
| ExclusionCriteria |
| Details |
- Contraindications to study medication as per approved label in the country.
- Patients who are not fit for the study as per the investigator’s discretion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Reduction in fever - Body temperature will be evaluated at timepoints.
- Reduction in pain - Pain intensity will be evaluated by using self-reported Visual Analogue Scale (VAS) score at timepoints. |
Fever and pain
- Day 0 (0 min, 15 min, 30 min, 1 Hour, 2hour, 4 hour and 6 hour)
- Day 1 thereafter once every day till recovery i.e.
- EOT maximum up to Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Patient reported side effects, adverse drug reactions and adverse events of special interest (AESI) like hepatic and renal adverse events will be assessed.
- Vital parameters like blood pressure [mm Hg], pulse rate [beats per minute], respiratory rate [breaths per minute] and physical examination will be assessed as additional safety parameters. |
- Day 0
- Day 1, till recovery
- EOT maximum up to Day 10 |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
Final Enrollment numbers achieved (Total)= "303"
Final Enrollment numbers achieved (India)="303" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/11/2023 |
| Date of Study Completion (India) |
01/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
This is a prospective, multi-center, comparative, observational study to assess the safety and efficacy of Nimesulide 100 mg tablets versus Ibuprofen plus Paracetamol, and Paracetamol. This study will be conducted at or up to five study sites in India. In this study, real world data generated will be compared to evaluate the safety and effectiveness of Nimesulide, Ibuprofen plus Paracetamol and Paracetamol alone in adult patients with fever or fever with pain. Patients will be divided into three groups based on study drug prescribed by the investigator. Total 303 patients will be enrolled in the study. Patients will be grouped as below: Group 1- Nimesulide 100mg tablets (N=101) Group 2- Ibuprofen (400mg) plus Paracetamol (325mg) (N=101) Group 3- Paracetamol (650mg) (N=101)
In this study, Nimesulide will be compared with Ibuprofen plus Paracetamol and Paracetamol alone by observing reduction in fever from 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours post consuming study drug by the patient and on Day 1 and thereafter once every day till recovery i.e. EOT maximum up to Day 10 using a thermometer; and by observing reduction in pain intensity via self-reported Visual Analogue Scale (VAS) provided by investigator from baseline to 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours, post dosing and on Day 1 and thereafter once every day till EOT maximum up to Day 10. Efficacy will be assessed under Full Analysis Set (FAS) and PP (per protocol) set. |