| CTRI Number |
CTRI/2025/06/088790 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| 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 clinical study to see the effect safety and tolerance of FDC of Aceclofenac 100mg & Paracetamol 500mg tablet compared to Aceclofenac Film-Coated Tablet 100mg & Paracetamol Tablets 500mg in the participant suffering with acute painful musculoskeletal conditions. |
|
Scientific Title of Study
|
A Randomized, Open Label, Parallel Group, Clinical Study to evaluate the efficacy, safety and tolerability of fixed-dose combination of Aceclofenac 100 mg plus Paracetamol 500 mg tablets of Ajanta Pharma Ltd. vs Beofenac 100 (Aceclofenac Film-Coated Tablets 100 mg) of Almirall, Spain and Panadol Advance 500 (Paracetamol Tablets 500 mg) of Glaxo Smith Kline S.A in the treatment of Acute Painful Musculoskeletal/Musculospastic Conditions. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/24/03 Version 00, Version date: 14-Nov-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. K. Sanjeev Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Government Medical College & Government General Hospital |
| Address |
Department of Orthopaedics
OPD No: 03
Ground Floor
Government Medical College & Government General Hospital Old RIMSGGH Srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
7702288992 |
| Fax |
|
| Email |
drsanjeevkumarkare@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Director Biosphere Clinical Research Pvt Ltd |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Biosphere Clinical Research Pvt Ltd
Office No 02 03 & 04 Second Floor
Highland Corporate Center
Kapurbawdi Junction Thane W 400 607
Maharashtra India
Thane
MAHARASHTRA
400607
India |
| Phone |
9029025200 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Director Biosphere Clinical Research Pvt Ltd |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Biosphere Clinical Research Pvt Ltd
Office No 02 03 & 04 Second Floor
Highland Corporate Center
Kapurbawdi Junction Thane W 400 607
Maharashtra India
Thane
MAHARASHTRA
400607
India |
| Phone |
9029025200 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| M/S Ajanta Pharma Limited Plot No. 43AB & 44BCD, Charkop Industrial Estate, Charkop, Kandivali (W),Mumbai – 400 067, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Limited |
| Address |
Plot No 43 AB and 44 BCD Govt Industrial Estate Charkop Kandivali West Mumbai 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 K Sanjeev Kumar |
Government Medical College & Government General Hospital |
Department of Orthopaedics, OPD No: 03, Ground Floor, Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam- 532001, Andhra Pradesh
Srikakulam
ANDHRA PRADESH |
7702288992
drsanjeevkumarkare@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College & Government General Hospital, Balaga Srikakulam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aceclofenac 100 mg plus Paracetamol 500 mg tablets |
One tablet of FDC of Aceclofenac 100 mg plus Paracetamol 500 mg tablets twice daily, one tablet in the morning and one in the evening for 7 days to be taken orally preferably with or after food. |
| Comparator Agent |
Beofenac 100 (Aceclofenac Film-Coated Tablets 100 mg) of Almirall, Spain and Panadol Advance 500 (Paracetamol Tablets 500 mg) of Glaxo Smith Kline S.A |
Co-administration of one tablet of Beofenac 100 (Aceclofenac Film-Coated Tablets 100 mg) and one tablet of Panadol Advance 500 (Paracetamol Tablets 500 mg) twice daily for 7 days, in the morning and in the evening to be taken orally preferably with or after food. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.
Male and female subjects 18 to 65 years of age (Both Inclusive).
2.
Subjects with acute painful musculoskeletal/musculospastic conditions like pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, minor pain of arthritis, muscular aches and backache.
3.
Subjects who have pain score of at least 4 on a Numerical Rating Scale (11- point scale).
4.
Subjects who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1.
Subject has known allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
2.
Subjects who have used NSAIDS or any other analgesic in last 24 hours.
3.
Subjects who have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the screening or intra-articular treatment injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period.
4.
Subjects with clinically significant uncontrolled cardiovascular disease.
5.
Subjects with history of peptic ulceration or active gastrointestinal (GI) bleeding or inflammatory bowel diseases.
6.
Subjects with a history/existing case of bronchial asthma.
7.
Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases or malignancies.
8.
Subjects with abnormal Liver Function Test (LFT) values more than 3 times the upper limit of normal.
9.
Subjects with renal dysfunction with serum creatinine value ≥ 1.5 mg/dl at screening.
10.
Subjects with known alcohol or other substance abuse within last one year as per DSM-5 criteria.
11.
Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
12.
Pregnant and lactating women or the women of child bearing age who are not ready to use effective means of contraception. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
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 (NRS) from Baseline to end of study that is 7th day of treatment. |
Reduction of pain as measured by Numerical Rating Scale (NRS) from Baseline to end of study that is 7th day of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from Baseline in the Subjects Global Assessment.
Change from Baseline in the Physician’s Global Assessment.
|
Baseline to end of study |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| 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="0"
Days="7" |
|
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
|
| Following a screening visit, Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized to receive either fixed-dose combination of Aceclofenac 100 mg plus Paracetamol 500 mg tablets of Ajanta Pharma Ltd. or Beofenac 100 (Aceclofenac Film-Coated Tablets 100 mg) of Almirall, Spain and Panadol Advance 500 (Paracetamol Tablets 500 mg) of Glaxo Smith Kline S.A . Subjects will be provided with subject’s diary card at randomization visit, which needs to be brought during each subsequent visit till the last visit. Follow up visit will be on Day 3 and Final Visit on Day 7 of treatment to assess efficacy, safety and tolerability. | |