| CTRI Number |
CTRI/2025/06/089084 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate safety & efficacy of 3-Drug Combination (Paracetamol,Chlorzoxazone, and Diclofenac Sodium) in comparison with 2 Drug Combination (Paracetamol and Diclofenac Sodium) in treating adult patients with acute musculoskeletal pain
because of spasm. |
|
Scientific Title of Study
|
A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate the safety & efficacy of the 3-Drug-Fixed Dose Combination (FDC) tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg, and Diclofenac Sodium 50 mg in comparison with 2-Drug-FDC tablet of Paracetamol 325 mg and Diclofenac Sodium 50 mg administered TID in adult patients with acute musculoskeletal pain associated with spasm. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSPL/2023/003 2.1 dated 13-Dec-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Agarwal |
| Designation |
Senior Consultant Orthopaedic Surgeon |
| Affiliation |
Prime Care Hospital |
| Address |
Department of Orthopaedics, B 403/404, Rudra Arcade, Near Helmet Cross Road, Ahmedabad-380052, Gujarat, India
Ahmadabad
GUJARAT
380052
India |
| Phone |
8140520005 |
| Fax |
|
| Email |
dragrawalpankaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharat B Doshi |
| Designation |
Chief Executive Officer |
| Affiliation |
BioDev Services Private Limited |
| Address |
A 804 Privilon Off SG Road ISKCON Ambli Road Ahmedabad GUJARAT 380059 India
Ahmadabad
GUJARAT
380059
India |
| Phone |
9586244544 |
| Fax |
|
| Email |
bharat.doshi@biodevservices.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharat B Doshi |
| Designation |
Chief Executive Officer |
| Affiliation |
BioDev Services Private Limited |
| Address |
A 804 Privilon Off SG Road ISKCON Ambli Road Ahmedabad GUJARAT 380059 India
GUJARAT
380059
India |
| Phone |
9586244544 |
| Fax |
|
| Email |
bharat.doshi@biodevservices.com |
|
|
Source of Monetary or Material Support
|
| Unison Pharmaceuticals Pvt. Ltd.
Near Prernatirth Derasar Near Ratnadeep II Satellite Jodhpur Ahmedabad 380 015 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Unison Pharmaceuticals Pvt. Ltd. |
| Address |
“Unison House” Near Prernatirth Derasar Near Ratnadeep II Satellite Jodhpur Ahmedabad 380 015 Gujarat India |
| 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 Chandan Kumar |
Ganesh Shankar Vidyarthi Memorial Medical College |
Department of Orthopaedics
Ganesh Shankar Vidyarthi Memorial Medical College
Department of Orthopedic Swaroop Nagar Kanpur 208002
Kanpur Nagar
UTTAR PRADESH |
9335313138
Ck131980@gmail.com |
| Dr Paramesha KC |
KR Hospital |
KR Hospital. Mysore Medical College and Investigator Research Institute, Irwin Road, Mysuru-570001
Mysore
KARNATAKA |
9343055819
parameshkennal@gmail.com |
| Dr Pankaj Agarwal |
Primecare Hospital |
Department of Orthopaedics
B-403/404 Rudra Arcade Near Helmet Cross Road Ahmedabad 380052 Gujarat India
Ahmadabad
GUJARAT |
8140520005
dragrawalpankaj@gmail.com |
| DrKshitij Shah |
Proactive orthopedic clinic |
Department of Orthopaedics
Ground floor Juhu Sagar Juhu Versova Link Rd Kapaswadi Andheri West Mumbai Maharashtra 400053
Mumbai
MAHARASHTRA |
9833040048
drkshitij22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee, GSVM Medical College |
Approved |
| Indira IVF Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Medilink Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAN MR |
DAN MR is the fixed dose combination of Paracetamol,Chlorzoxazone and Diclofenac sodium. Combination of these drugs provide anti- inflammatory as well as analgesic effect and will help to eliminate the larger dose of the analgesics and yet attain the results. To reduce the pill burden on the patient and increase the patient compliance, the drugs could be given in a fixed dose combination. Hence the study focuses on the safety evaluation of the 3 Drug-FDC in the patients experiencing pain. |
| Comparator Agent |
DAN P |
DAN P, 2-Drug fixed dose combination of Paracetamol 325 mg + Diclofenac sodium 50 mg (Oral Tablet, TID) is approved for the treatment of acute pain. The drug has to be taken as prescribed by the physician till pain subsides. In current study, drug will be taken till day 8 or resolution of symptoms whichever occurs first. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
01. Patients who have given their written consent to participate voluntarily and agrees to adhere to the protocol for completion of study.
02.Male and Female between the age of 18 to 60.
03.Patient is able to take oral medication and is willing to comply with the treatment schedule as well as all study procedures.
04.Patient’s willingness to comply with all study procedures and availability for the duration of the study.
05.Female participants must be non-lactating, not pregnant, and utilizing a reliable method of contraception, such as abstinence, an intrauterine device (IUD), or a male partner who agrees to use condoms.
06.Male participants must agree to use a reliable method of contraception, such as abstinence, condoms, or having a partner who utilizes an intrauterine device (IUD).
07.Patients diagnosed (by the treating physician/PI) to have Acute Painful musculospastic condition such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low-backpain, tendonitis, tenosynovitis, bursitis, and as self-rated 7-10 on the Numerical pain scale.08.Patients must agree to abstain from consuming Alcohol, any other substance of abuse during their participation in the trial.
|
|
| ExclusionCriteria |
| Details |
01. Active participation in any other clinical trial.
02. Known allergy to the study drugs used in the trial. (Diclofenac, Paracetamol, Chlorzoxazone).
03. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy as judged by the investigator.
04.Patients taking any other medicine that might interact with one of the study medications.
05.History of auto-immune disease.
06.Active peptic ulcer disease.
07. Pregnant females, lactating women or women of childbearing age who are not using an acceptable method of birth control.
08. Patients with a history of epilepsy, or those at-risk seizures or taking antiepileptic drugs.
09. Patient with known G6PD deficiency.
10.Patients with pre-existing gallbladder disease.
11. Patients with galactose or fructose intolerance
12. Patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities.
13. Alcohol dependence or any other condition that may affect the study, as assessed by the Investigator.
14. Patients with concomitant use of other NSAIDs, antiplatelets, anticoagulants or any other aid for pain.
15. Patients needing any treatment (associated with muscle spasm) other than the study drugs - as diagnosed by the Investigator.
16. Any history/ symptoms/ suspicion of patients having hepatic or renal impairment, as judged by the Principal Investigator.
17. If patient is on any other treatment or additional treatment aid for pain (oral, dermal, drug-plaster, heat-pad or any similar contact therapy, herbal, homeopathic or any other nature) during the study duration.
18. Patients with any severe and/or uncontrolled medical conditions or other conditions that, in the investigator’s opinion may affect the patient’s participation in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of patients who shows any incidence of drug associated adverse effect during 8 days of treatment
Percentage of patients where the PI needs to stop the treatment before day 8 due to drug-associated toxicity |
Percentage of patients who shows any incidence of drug associated adverse effect during 8 days of treatment
Percentage of patients where the PI needs to stop the treatment before day 8 due to drug-associated toxicity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage reduction in pain at day 8
Percentage of the patients where the PI stops the treatment before the day 8, as the pain has subsided & the need for pain management does not exist anymore. |
8 Days |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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) |
Open to Recruitment |
|
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
|
A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate the safety & efficacy of the 3-Drug-Fixed Dose Combination (FDC) tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg, and Diclofenac Sodium 50 mg in comparison with 2-Drug-FDC tablet of Paracetamol 325 mg and Diclofenac Sodium 50 mg administered TID in adult patients with acute musculoskeletal pain associated with spasm. 200 subjects (adult male/female patients of age Between 18 -60) having moderate to severe pain, who are diagnosed by rating the pain between grade 7 to 10 on numeric pain scale by principal investigator, would be screened for enrolment, as per Inclusion/Exclusion criteria. Age: 18 Years to 60 Years (inclusive of both). Assessment by Percentage of patients who shows any incidence of drug associated adverse effect will be evaluated as a primary end-point and efficacy in terms of % pain reduction will be the secondary objective of the study. |