| CTRI Number |
CTRI/2025/01/079095 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A MultiCenter Post-Marketing Surveillance Study to generate data on Safety and Tolerability of Diclofenac Sodium 75mg/ml Injection in Patients with Acute Painful Conditions. |
|
Scientific Title of Study
|
A Prospective, Open-label, Non-Comparative, Non-interventional, Multi-center, Active Post
Marketing Surveillance (PMS) study to Assess the safety and tolerability of Diclofenac sodium
75mg/ml Injection manufactured by Themis Medicare Ltd, in patients with acute painful conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TML/DIL/01 Version 01 Dated 01 MAR 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambanna Gowda |
| Designation |
Consulting physician |
| Affiliation |
Citizen Hospital |
| Address |
Citizen Hospital, #14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore 560002
Citizen Hospital, #14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9845270377 |
| Fax |
|
| Email |
gowdaambanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balaji More |
| Designation |
Vice President - Medical |
| Affiliation |
Themis Medicare Ltd. |
| Address |
Themis Medicare Ltd.
11/12, Udyog Nagar, S.V.Road
Goregaon (W), Mumbai
Themis Medicare Ltd.
11/12, Udyog Nagar, S.V.Road
Goregaon (W), Mumbai
Mumbai
MAHARASHTRA
400104
India |
| Phone |
8452959225 |
| Fax |
|
| Email |
balaji.more@themismedicare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balaji More |
| Designation |
Vice President - Medical |
| Affiliation |
Themis Medicare Ltd. |
| Address |
Themis Medicare Ltd.
11/12, Udyog Nagar, S.V.Road
Goregaon (W), Mumbai
Themis Medicare Ltd.
11/12, Udyog Nagar, S.V.Road
Goregaon (W), Mumbai
Mumbai
MAHARASHTRA
400104
India |
| Phone |
8452959225 |
| Fax |
|
| Email |
balaji.more@themismedicare.com |
|
|
Source of Monetary or Material Support
|
| Themis Medicare Ltd.
11/12, Udyog Nagar, S.V. Road
Goregaon (W), Mumbai - 400 104
Website: www.themismedicare.com
|
|
|
Primary Sponsor
|
| Name |
Themis Medicare Ltd. |
| Address |
11/12, Udyog Nagar, S.V. Road
Goregaon (W), Mumbai - 400 104
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinical Research Network India Pvt Ltd |
B-806, 807 Advant Navis Business Park, Plot #7,
Noida-Greater Noida Expressway, Sector 142,
Noida, Delhi-NCR, Uttar Pradesh 201305
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambanna Gowda |
Citizen Hospital |
Department of General medicine, consultation room, Kalasipalya Extn, Bangalore-Urban Karnataka 560002
Bangalore
KARNATAKA |
9845270377
gowdaambanna@gmail.com |
| Dr Vinod Kumar Kapoor |
New Leelamani Hospital |
Department of General medicine, ground floor,14/116, C-1 Parade Chauraha, Civil lines Kanpur 208001
Kanpur Dehat
UTTAR PRADESH |
9555989176
drvinodkumarkapoor@gmail.com |
| Dr Jitendra Singh Kushwaha |
Prakhar Hospital Pvt Ltd |
Department of General medicine, ground floor, 8/219 Arya Nagar Kanpur, Uttar Pradesh-208002
Kanpur Dehat
UTTAR PRADESH |
7905113329
dr.jskushwahacr@gmail.com |
| Dr Azad Khan |
Shubharti medical College & Hospital |
Department of Orthopedics,
Division 1, Room no 5
Shubhartipuram NH-58 Delhi-Haridwar bypass Meerut, U.P -250005
Meerut
UTTAR PRADESH |
9319837319
azd4mrt@gmail.com |
| Dr Amjad Khan |
Unitree Health Care & Diagnostics |
Department of General Medicine, consultant room, 38/1, Church Road, Narappa Garden J.C Nagar, Bangalore, 560006
Bangalore
KARNATAKA |
9886855985
dr.pathan05@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Citizen Hospital Institutional Citizen Wellness LLP, new 14, 2nd Main Road, Kalasipalya Extn. Bangalore Urban 560002 Ethics Committee |
Approved |
| Citizen Hospital Institutional Citizen Wellness LLP, new 14, 2nd Main Road, Kalasipalya Extn. Bangalore Urban 560002Ethics Committee |
Approved |
| Institutional Ethics Committe Prakhar Hospital Pvt. Ltd, 8/219 Arya Nagar Kanpur, Uttar Pradesh-208002 e Prakhar Hospital |
Approved |
| Institutional Ethics Committe Shubharti Medical College & Hospital, Shubhartipuram NH-58 Delhi-Haridwar bypass, Meerut U.P -250005 e , Shubharti Medical College & Hospital, Meerut |
Approved |
| Institutional Ethics Committee-Leelamani Hospital New leelamani Hospital, 14/116 B, C, C-1D, 1 Civil Lines, Kanpur, Uttar Pradesh 208001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac 75mg/ml Injection (1 ml ampoule) |
Diclofenac Sodium BP........... 75 mg
Benzyl Alcohol BP…………2% v/v
Water for Injections BP………Q.S.
Patients will be prescribed/administered Diclofenac injection (study drug)75 mg once
or twice daily by IM or IV route as per study investigator’s discretion for 2 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients of greater than or equal to 18 years of age 2. Patients requiring diclofenac injection for management of painful conditions in post-operative condition 3. Patients/LAR who agree to give informed consent |
|
| ExclusionCriteria |
| Details |
1. Any of the contraindications to use of the study investigational product, as per the Prescribing Information
a. Known hypersensitivity to the active substance or to any of the excipients
b. Active gastric or intestinal ulcer, bleeding or perforation
c. Last trimester of pregnancy
d. History of severe hepatic, renal or cardiac failure
e. Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs
f. Haemostasias disorders or current anticoagulant treatment (for intramuscular route of administration only)
g. Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Specifically, for I.V. use
h. Concomitant NSAID or anticoagulant use (including low dose heparin).
i. History of hemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding
j. Operations associated with a high risk of hemorrhage
k. A history of asthma
l. Moderate or severe renal impairment (serum creatinine greater than 160 µmol/L)
m. Hypovolemia or dehydration from any cause
2. A subject who is judged by the investigator as inappropriate
to participate in the study for any reason other than those mentioned above.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Number of adverse events during the study period |
1. Number of adverse events from baseline (Day 1) to End of study (Day 3). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of SAEs during the study period.
2. Incidence of all SAEs unrelated/related to study drug during the study.
3. Incidence of all Adverse Drug Reactions (AEs related to study drug) during the study.
4. Incidence of Injection Site Reaction (ISR) during the study.
5. Incidence of any Adverse Drug Reactions referring to renal toxicity during the study.
6. Overall Efficacy of study drug (Change in Pain from baseline to end of study as assessed on 100mm VAS scale.)
7. Overall Tolerability reported by physician at the end of the study. |
Safety will be assessed from baseline (Day 1) to End of study (Day 3). |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/02/2025 |
| 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="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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, Open-label, Non-Comparative, Non-interventional, Multi-center, Active Post Marketing Surveillance (PMS) study under a structured protocol to monitor and assess safety of Diclofenac sodium 75mg/ml Injection during the real-world usage. All treatment and monitoring of the patients will be done at the discretion of the treating physician (Investigator). The study will include 200 subjects including male & female patients of greater than or equal to 18 years of age with acute painful conditions in post operative conditions. |