| CTRI Number |
CTRI/2021/01/030262 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A single dose observational study to assess the local tolerability of Diclofenac AQ Injection (Diclofenac Sodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India.) |
|
Scientific Title of Study
|
A multicentric, open labelled, non-comparative, single dose observational study to assess the local tolerability of
Diclofenac AQ Injection(DiclofenacSodium 75 mg/ml injection manufactured by Akums Drugs and
Pharmaceuticals Ltd., India.) upon Intramuscular administration in patients having severe inflammatory or
spasmodic pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Madini |
| Designation |
Consultant Orthopedic Surgeon |
| Affiliation |
Sparsh Hospitals and Critical Care Private Limited |
| Address |
Dept of Orthopedics
GROUND FLOOR
Sparsh Hospitals and Critical Care Private Limited
A 407
Sahid Nagar
Bhubaneswar
Dept of Orthopedics
GROUND FLOOR
Sparsh Hospitals and Critical Care Private Limited
A 407
Sahid Nagar
Khordha
ORISSA
751007
India |
| Phone |
750415598 |
| Fax |
|
| Email |
mkmanojcatchme9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saiprasanna Behera |
| Designation |
Director |
| Affiliation |
CRO PHARMATRENDZ PRIVATE LIMITED |
| Address |
GROUNG FLOOR
PLOT NUMBER F 29
BJB NAGAR BHUBANESWAR
GROUND FLOOR
PLOT NUMBER F 29
BJB NAGAR BHUBANESWAR
Khordha
ORISSA
751014
India |
| Phone |
9861252518 |
| Fax |
|
| Email |
drsai@pharmatrendz.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Sharma |
| Designation |
Sr Manager DRA |
| Affiliation |
Akums Drugs and Pharmaceuticals Limited |
| Address |
304
Mohan Place
L.S.C. Block-C
Saraswati Vihar
304
Mohan Place
L.S.C. Block-C
Saraswati Vihar
North West
DELHI
110034
India |
| Phone |
|
| Fax |
|
| Email |
sharmamamta0617@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akums Drugs and Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Akums Drugs and Pharmaceuticals Limited |
| Address |
#304 Mohan Place Local Shopping Complex Block C Saraswati
Vihar New Delhi 110034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Kumar Jangid |
Hi Tech Medical College & Hospital |
Health Park, Pandara, Bhubaneswar-751025
Khordha
ORISSA |
9439129178
drsanjaykjangid@gmail.com |
| Dr Vikalp Vashishtha |
Maharaja Agrasen Superspecialty Hospital |
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN |
09252992573
drvikalpvashishth@gmail.com |
| DrManoj Madini |
Sparsh Hospitals and Critical Care Private Limited |
Dept of Orthopaedics
A/407 Sahid Nagar Bhubaneswar
Khordha
ORISSA |
7504115598
mkmanojcatchme9@gmail.com |
| Dr Sunil Maheswari |
Tapan Research Centre |
Tapan Research Centre
Basement Tapan Hospital
Near Platinum Hall
Anandnagar Cross Road
Satellite
Ahmadabad 380015
Ahmadabad
GUJARAT |
09586710141
drsunilmaheshwari10@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| ACEAS- Independent Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE JEEVAN REKHA HOSPITAL |
Approved |
| Institutional Ethics Committee Maharaja Agrasen Super specialty Hospital |
Approved |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having severe inflammatory or spasmodic pain with VAS score up to 7 (mild to moderate pain) and requiring immediate relief.
2. Patients who are able to and willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to the drug components or other drug from same class
2. Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (eg benzodiazepines) for the duration of their participation in the study
3. Patient with history of drug of abuse
4. Patients recently diagnosed any viral or bacterial infection
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the local tolerability of Diclofenac AQ Injection (Diclofenac Sodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India) upon intramuscular administration in patients having severe inflammatory or spasmodic pain |
24 hours post injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the adverse events.
Global assessment by patient at the end of study
Global assessment by physician at the end of study
|
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this
study is to assess the local tolerability of Diclofenac AQ Injection(Diclofenac
Sodium 75 mg/ mL injection manufactured by Akums Drugs and Pharmaceuticals
Ltd., India) upon IM administration in patients having severe inflammatory or
spasmodic pain in a multicentric, open labelled, non-comparative, single dose
observational clinical trial
Skeletal muscle
spasm results from inflammation that occurs when a muscle is overstretched or
torn. It begins as a muscle strain, which doesn’t sound like a serious injury,
but it can cause severe low back pain. Many people go to the emergency room
each year because of a muscle strain. In fact, most episodes of acute lower
back pain are caused by damage to the muscles and/or ligaments in the low back.
Muscle strains
are also known as a pulled muscle. When the muscles in the lower back are
strained or torn, the area around the muscles can become inflamed. With
inflammation, the muscle can spasm leading to severe low back pain and
difficulty moving.
Muscle spasms
range in intensity from mild twitches to severe pain. The spastic muscle may
feel harder than normal to touch, and/or appear visibly distorted. Causes of
skeletal muscle spasm are lifting of heavy object, lifting while twisting, or a
sudden movement or fall |