| CTRI Number |
CTRI/2023/09/057622 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A post marketing study to assess the safety and efficacy of Four different pain killer combinations in patients with acute painful conditions |
|
Scientific Title of Study
|
A prospective, open-label, multicentre, active controlled, comparative, post marketing study to evaluate the safety and efficacy of FDC of nimesulide-paracetamol as compared to FDC of aceclofenac-paracetamol, ketorolac and FDC of diclofenac-paracetamol in patients with acute painful conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Clinexcel/23/103 Version 02 Dated 08/07/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajitkumar Gondane |
| Designation |
Medical Advisor |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Ltd., Alkem House, Lower Parel (W)
Mumbai
MAHARASHTRA
400013
India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
8983375722 |
| Fax |
|
| Email |
ajitkumar.gondane@alkem.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajitkumar Gondane |
| Designation |
Medical Advisor |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Ltd., Alkem House, Lower Parel (W)
Mumbai
MAHARASHTRA
400013
India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
8983375722 |
| Fax |
|
| Email |
ajitkumar.gondane@alkem.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Medical Director |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, SoBo Centre, South Bopal, Ahmedabad 380058
Ahmadabad
GUJARAT
380058
India
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
|
Source of Monetary or Material Support
|
| Alkem Laboratories Ltd., Alkem House, Lower Parel (W), Mumbai - 400013
|
|
|
Primary Sponsor
|
| Name |
Alkem Laboratories Limited |
| Address |
Alkem House, Lower Parel (W), Mumbai - 400013 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan Patel |
Aatman Hospital |
Research Room,
Basement, Aatman
Hospital, 5, Anveshan
Row House, Bopal
Ghuma Road
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Swati Makhija |
Makhija Dental Clinic |
OPD Room, E-300,
SoBo Centre, South
Bopal
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
8980568746
drswatimakhija@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee, Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (3) ICD-10 Condition: M658||Other synovitis and tenosynovitis, (4) ICD-10 Condition: S934||Sprain of ankle, (5) ICD-10 Condition: G438||Other migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aceclofenac 100mg and
Paracetamol 325mg tablets |
one tablet to be taken twice
daily every 12 hourly for
maximum of 10 days |
| Comparator Agent |
Diclofenac 50 mg and Paracetamol 325 mg tablets |
one tablet to be taken twice daily every 12 hourly for maximum of 10 days |
| Comparator Agent |
Ketorolac 10mg tablets |
one tablet to be taken thrice daily
(every 8 hourly) for maximum of
7 days |
| Intervention |
Nimesulide 100mg and
Paracetamol 325mg tablets |
one tablet to be taken twice
daily every 12 hourly for
maximum of 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender >_ 18 years of age
2. Patients with acute painful conditions like low back pain, acute musculoskeletal disorders and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures and post-surgical pain receiving either FDC of
nimesulide-paracetamol or FDC of aceclofenac-paracetamol or
ketorolac as per routine clinical practice
3. 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 >_ 3 x
Upper Normal Limit) or renal dysfunction (serum creatinine >_ 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
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of pain as measured by numerical
rating scale as compared to baseline in the Four
groups |
07 Days & 14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in liver function tests/parameters from
baseline to Week 2. [LFT will be assessed by AST, ALT, Serum Bilirubin] in the four groups |
14 days |
Change in renal function tests/parameters from
baseline to Week 2. [KFT will be assessed by
serum creatinine & blood urea nitrogen] in the
four groups |
14 days |
Gastrointestinal adverse events reported (any
epigastric pain, upper GI bleeding, peptic ulcer,
etc.) during the two weeks follow-up in the four
groups |
7 days & 14 days |
Cardiovascular adverse events (any MI, any
stroke or any CV death) during the two weeks
follow-up in the four groups |
7 days & 14 days |
Other Adverse events reported during the two
weeks follow-up in the four groups |
14 days |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
25/09/2023 |
| 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 Yet Recruiting |
| 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
|
Various NSAIDS and their combinations with paracetamol have been approved in India and are being used for management of patients with various painful conditions. All these NSAIDs have some differences in the pharmacodynamics and pharmacokinetic properties having an overall impact on the efficacy and safety of the products. The current post marketing study is being undertaken to evaluate and compare the safety and efficacy of the four commonly used combination of NSAIDS i.e. Nimesulide (100mg) + Paracetamol (325mg) tablets, Aceclofenac (100mg) + Paracetamol (325mg) tablets ,Ketorolac (10mg) tablet, and Diclofenac (50mg)+ Paracetamol (325mg) tablets in patients with acute painful conditions like low back pain, acute musculoskeletal disorders and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures and post-surgical pain. The patients enrolled in the study will be randomly given either of the four study drugs for management of their painful conditions as per investigators discretion as per routine clinical practice for the duration not exceeding 10 days for Nimesulide (100mg) + Paracetamol (325mg) tablets, Aceclofenac (100mg) + Paracetamol (325mg) tablets and Diclofenac (50mg)+ Paracetamol (325mg) tablets & 7 days for Ketorolac (10mg) tablet. The patients will be followed upto 14 days after study initiation. The patients will be followed up on weekly intervals and will undergo clinical examination and laboratory investigations to evaluate the efficacy, safety and tolerability of the four medications. |