| CTRI Number |
CTRI/2025/02/080922 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study designed to assess how safe, well-tolerated, and effective a combination of two medicines, Nimesulide and Paracetamol, is for people with long-term pain. |
|
Scientific Title of Study
|
A prospective, single arm, post-marketing, investigator-initiated study to evaluate safety, tolerability and efficacy of fixed dose combination (FDC) of Nimesulide and Paracetamol in patients with chronic painful conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PL/IIS/24/01 Version 01 Dated 25/06/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre, South Bopal,
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre, South Bopal,
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre, South Bopal,
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
|
Source of Monetary or Material Support
|
| Investigator Initiated Study (Clinical research room, 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad, 3800058, Gujarat, India :Dr. Prateek Lodha) |
|
|
Primary Sponsor
|
| Name |
Dr. Prateek Lodha |
| Address |
(5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad, 3800058, Gujarat, India. |
| Type of Sponsor |
Other [[ Self (Principal Investigator) ]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prateek Lodha |
Aatman Hospital |
Basement, Clinical Research Department room, Aatman Hospital 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad, 3800058
Ahmadabad
GUJARAT |
7574814462
prateeklodha86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nimesulide (100mg) + Paracetamol (325mg) tablets |
One tablet of Nimesulide (100mg) + Paracetamol (325mg) tablets twice daily for 3 to 4 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender more than 18 years of age
2. Patients with chronic painful conditions such as osteoarthritis knee, OA hip, frozen
shoulder, bursitis, chronic ligament injury / sprain requiring treatment with FDC of
nimesulide-paracetamol for 3 to 4 weeks time as per routine clinical practice
3. Patients willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients with past history of hypersensitivity to study drugs
2. Patients who have used NSAIDS or any other analgesic in last 24 hours
3. Patients with history of GI bleeding
4. Patients with clinically significant uncontrolled cardiovascular disease
5. Patients with hepatic dysfunction (serum transaminases more 3 x Upper Normal Limit)
or renal dysfunction (serum creatinine more 2.5 mg/dl) at screening
6. Pregnant and lactating mothers and women of child bearing potential who are not
taking adequate contraceptive measures
7. Patients prescribed / require any other medication known to interact with the study
medication.
8. Any other reason for which the investigator feels that the patient should not
participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in liver function (AST, ALT, Serum Bilirubin) tests, Change in renal function, change in heart burn score |
from baseline to Week 1 / 2 / 3 and 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain as measured by the numerical rating scale (NRS) |
at the end of week 1, week 2, week 3 and week 4 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="1"
Months="0"
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
|
In this study, patients with chronic painful conditions (osteoarthritis knee, OA hip, frozen shoulder, bursitis, chronic ligament injury / sprain) will be prescribed with FDC of nimesulide-paracetamol according to the investigator’s discretion as per routine clinical practice. The patients will be followed up on an outpatient basis on Day 7 (Visit 2), Day 14 (Visit 3), Day 21 (Visit 4), and Day 28 (Visit 5). Visit 4 or Visit 5 may be considered the end of-study visit, depending on the duration of treatment required by the patient. Primary endpoints of the study are change in liver, renal and Heart burn score from baseline to week 1,2,3 and 4. For the effectiveness reduction of pain measured by NRS scale at the end of week 1,2,3 and 4. |