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CTRI Number  CTRI/2024/06/069581 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness And Safety Of Polmacoxib Capsule In The Management of Hip/Knee Osteoarthritis. 
Scientific Title of Study   A Multi-Centric, Prospective, Single Arm, Open label Post Marketing Observational Study To Evaluate The Effectiveness And Safety Of Polmacoxib 2mg Capsule In Patients With Hip/Knee Osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Verma 
Designation  Principal Investigator  
Affiliation  Jawaharlal Nehru Medical College 
Address  101, Department of Orthopedics Jawaharlal Nehru Medical College, Kala Bagh, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9460077585  
Fax    
Email  drrakeshverma2008@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kartik Peethambran  
Designation  Associate Director - Medical Affairs 
Affiliation  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Private Limited Floor 18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E),

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  912250462305  
Fax    
Email  kartik.peethambaran@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director -Clinical Development & Operation 
Affiliation  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Private Limited Floor 18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E),

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  912250460456  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Private Limited Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051, India 
 
Primary Sponsor  
Name  Abbott Healthcare Private Limited 
Address  Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra(E) Mumbai – 400 051, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajiv Gupta  Bhandari Hospital and Research Centre,   Room no 504, Department of Orthopedics 138-A, Tonk Rd, Vasundhara Colony, Gopal Pura Mode, Jaipur, Rajasthan- 302018
Jaipur
RAJASTHAN 		 9799054124

rajivguptabhrc@gmail.com 
Dr K Sanjeev Kumar  Government Medical College And General Hospital  205, 2nd Floor, Research Wing,Beside FM Ward, Government Medical College & Government General Hospital, Srikakulam-532001
Srikakulam
ANDHRA PRADESH 		 9948741133

drsanjeevkumarkare@yahoo.com 
Dr Rakesh Verma  Jawaharlal Nehru Medical College  Room no 101, Department of Orthopedics Jawaharlal Nehru Medical College Kala Bagh, Ajmer- 305001
Ajmer
RAJASTHAN 		 9460077585

drrakeshverma2008@gmail.com 
Dr Pravin Waghmare  Punawale Multispeciality Hospital  Room no 205, Department of Orthopedics S.No 11/2/4, Alpha Heights, Vishnu Dev Nagar, Punawale, Pimpri-Chinchwad, Pune-411033
Pune
MAHARASHTRA 		 8308391683

drwaghmarepravin23@gmail.com 
Dr Ajit Kumar Kar  Shanti Memorial Hospital  Room no 201, Department of Orthopedics Thoria Sahi, Patnaik Colony, Mangalabag,Cuttack, Odisha-753001
Cuttack
ORISSA 		 8249935725

ajittapu12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Bhandari Hospital & Research Centre Institutional Ethics Committee  Approved 
Ethics Committee, Shanti Hospital  Approved 
IEC GMC and GGH Srikakulam  Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College   Approved 
SKINOVATE INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Polmacoxib 2mg Capsule  In this PMS patients patients with knee or hip osteoarthritis will receive Ppolmacoxib 2mg capsule, Once A Day, for a period of 6 weeks, as per the routine clinical practice and label. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male and female patients in the age group of 20 to 70 years, with a clinical diagnosis of knee or hip osteoarthritis as per the discretion of investigators.
2.Patients having chronic pain for 3 months or more due to osteoarthritis.
3. The baseline (predose) mean WOMAC pain score in the index joint is between 4 and 8.
4. Patients willing to provide written informed consent and comply with study procedures  
 
ExclusionCriteria 
Details  1. Use of any analgesics except the study medication or acetaminophen 24 hours before study drug administration and during the study.
2. Use of anticoagulants within 2 weeks before study enrollment.
3. Use of corticosteroids, herbal medicines, traditional ayurvedic medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate within 3 months before study enrollment.
4. Requirement for knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study.
5. Hypersensitivity or allergy to NSAID.
6. Pregnant and lactating women.
7. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock; history of New York Heart Association stage II-IV congestive heart failure, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, and/or cerebrovascular disease; pregnancy, breast-feeding, or expecting conception within the duration of the study; active ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months before randomization; ongoing chronic symptoms or psychiatric disorders preventing compliance with study procedures, except for subjects who were physically healthy and had been receiving the specified allowed drugs for ≥3 months; use of corticosteroids, intra-articular steroids or hyaluronic acid injections within 1 month of screening; chemotherapy within 5 years.
8. Patients with any other conditions or diseases that the investigator considers inappropriate to enter the study as per prescribing information
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. The mean change in the pain subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis  Week 6 
 
Secondary Outcome  
Outcome  TimePoints 
1. The mean change in the stiffness subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis.
2.The mean change in the physical function subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis.
3. The mean change in the total Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis. 		 Week 3 and 6 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) 25/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Results of study “Evaluation of Polmacoxib 2 mg for the Management of Hip and Knee Osteoarthritis: A Prospective, Single-Arm, Multicenter, Open-Label Study” are published in Cureus (https://www.cureus.com/articles/396429-evaluation-of-polmacoxib-2-mg-for-the-management-of-hip-and-knee-osteoarthritis-a-prospective-single-arm-multicenter-open-label-study#!/ ).  
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, multicenter, single-arm, open-label, post-marketing observational study designed to evaluate the effectiveness and safety of polmacoxib 2 mg capsule in the management of hip or knee osteoarthritis in patients in the age group of ≥20 to ≤70 years. This multicenter study will enroll approximately 150 adult patients with hip or knee osteoarthritis. The patients will be followed up for 8 weeks  (6 weeks of treatment + 2-week follow-up) after enrollment into the study.


 
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