CTRI/2024/10/075701 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On:
16/05/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Longterm Safety and efficacy of polmacoxib in Indian patients
Scientific Title of Study
A Phase IV, Post-marketing, Prospective, Multicenteric, Single Arm, Non-comparative
Study to Evaluate the Safety and Efficacy of Polmacoxib 2mg in Adult Patients with
Osteoarthritis of Hip/Knee
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
HCR/IV/POLMOA/07/2023 Version 1.0 Dated 10-07-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shubhadeep Sinha
Designation
Senior Vice-President
Affiliation
Hetero Labs Limited
Address
Clinical Development and Medical Affairs,
Hetero Drugs Limited,
7-2-A2, Industrial Estates, Sanath Nagar
Hyderabad - 500018, India,
Hyderabad TELANGANA 500018 India
Phone
23704923
Fax
23801902
Email
sd.sinha@heterodrugs.com
Details of Contact Person Scientific Query
Name
Dr Sreenivasa Chary
Designation
Senior General Manager
Affiliation
Hetero Drugs Limited
Address
Clinical Development and Medical Affairs,
Hetero Drugs Limited,
7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India,
Hyderabad TELANGANA 500018 India
Phone
237049232425
Fax
23801902
Email
sreenivasa.chary@heterodrugs.com
Details of Contact Person Public Query
Name
Dr Shubhadeep Sinha
Designation
Senior Vice-President
Affiliation
Hetero Drugs Limited
Address
Clinical Development and Medical Affairs,
Hetero Drugs Limited,
7-2-A2, Industrial Estates, Sanath Nagar
Hyderabad - 500018, India,
Civil Hospital, Sola,
Department of Orthopaedic Surgery,
Ground Floor,Room No 4
Solagram, Rd. Beside High Court,
Ahmedabad-380060, India Ahmadabad GUJARAT
9033023000
bjesalpura@yahoo.com
Dr Kishore Babu Sattaru
Government Medical College & Govt General Hospital (Old RIMSGGH)
Department of Orthopaedics,Ground Floor,Room No 3, 532001, India Srikakulam ANDHRA PRADESH
9885422945
rimsresearch@gmail.com
Dr Brijesh Patel
Hi-Tech Multispeciality Hospital
Department of Orthopedic
Ground Floor, Room no 3, Sector3-D, Plot No.1180, Gh Road, Nr. Gh-11/2 Bus stand
382003,India Gandhinagar GUJARAT
9825686088
hitechhospital.cr@gmail.com
Dr Rakesh Verma
Jawahar Lal Nehru Medical College
Department of Orthopaedic,
Ground Floor,Room No 22
Kala Bagh, Ajmer-305001, India Ajmer RAJASTHAN
9460195960
rakeshverma.jln@outlook.com
Dr Kiran Kumar Mukhopadhyay
Nil Ratan Sircar Medical College and Hospital
Department of Orthopaedics,
First Floor, Room No 6,
138, AJC Bose Road,700014,
India Kolkata WEST BENGAL
9433166270
orthokiran@gmail.com
Dr Mukesh Kumar Aswal
SMS Medical College
Department of Orthopaedics, Ground Floor, Room No-11, Dhanvantri OPD Block, JLN Marg – 302004 Jaipur RAJASTHAN
9950222412
dr.mukeshaswal@gmail.com
Dr Tadikonda Bhavani Prasad
Visakha Institute of Medical Sciences
Department of Orthopaedics,
Ground Floor, Room No 5, Visakhapatnam-530040,
Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
Ethics Committee NRS Medical College NRS Medical College and Hospital, 138 AJC Bose Road, Kolkata-700014
Submittted/Under Review
Ethics Committee, S.M.S Medical College and Attached Hospitals J.L.N. Marg Jaipur, Rajasthan - 302004
Approved
Hi-Tech Ethics Committee Hi-Tech Multispeciality Hospital Sector 3-D,Plot No.1180,Gh Road, Nr.Gh-11/2 Bus stand Gandhinagar -382003 Gujarat,India
Submittted/Under Review
Institutional Ethics Committee Government Medical College & Govt General Hospital, Srikakulam - 532001, Andhra Pradesh,India
Submittted/Under Review
Institutional Ethics Committee Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001, Rajasthan,India
Approved
Institutional Ethics Committee, GMERS Medical College, Sola, GMERS Medical College,Civil Hospital, Sola, High Way Near Gujarat High Court Ahmedabad-380060 , Gujarat India
Submittted/Under Review
Institutional Ethics Committee, Visakha Institute of Medical Sciences S.No.97/2 Hanumathwaka, Chinnagadili Village, Visakhapatnam 530040, Andhra Pradesh, India
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M160||Bilateral primary osteoarthritis of hip, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NA
Not required
Intervention
Polmacoxib 2 mg
Once daily after breakfast for 6 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Males or females patients 18 years or above, who are able and willing to provide written informed consent.
2. Knee or Hip OA diagnosed according to clinical and imaging criteria specified by the American College of Rheumatology guidelines.
3. Patients with chronic pain for ≥ 3 months from OA.
4. Patients with radiographic osteoarthritic changes of grade ≥2 of Kellgren and Lawrence system of osteoarthritis classification1
5. Patients with index joint pain of at least moderate to severe intensity as measured by visual analog scale (VAS) recording of ≥40 mm (0–100 mm)
6. Patients (Women of childbearing potential and their partners) must agree to use barrier contraception during the study period and for 3 months afterward and neither become pregnant or lactate.
ExclusionCriteria
Details
1. Patients with history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol.
2. Patients with medical conditions of active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to screening.
3. Patients with History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock.
4. Patients with history of congestive heart failure with a status of New York Heart Association II-IV, ischemic heart disease,
uncontrolled hypertension (controlled hypertension for more than 3 months prior to screening are eligible), peripheral arterial disease, cerebrovascular disease.
5. Patients with a recent history (1 year) of drug or alcohol abuse (2 or less drinks per day allowed) or dependence
6.Patients who are not suitable to participate in the study
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Treatment emergent clinical & laboratory adverse events (TEAEs) during the
treatment period.
week 6
Secondary Outcome
Outcome
TimePoints
1. Change from baseline to Week 6 in the WOMAC Total OA Index and Subscales Scores.
week 6
2. Change from baseline to Week 6 in Pain Score measured by VAS scale.
Week 6
Change from baseline to Week 6 in Subjects Global
Assessment
Week 6
Change from baseline to Week 6 in Physicians Global
Assessment
Week 6
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)
04/11/2024
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 Yet Recruiting
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
This is a Phase IV, post-marketing, prospective, multicenteric, single-arm, non-comparative study to evaluate the safety and efficacy of Polmacoxib 2 mg in adult patients with osteoarthritis of
Hip/Knee. Evaluation of the safety of polmacoxib in patients with osteoarthritis (OA) of hip/knee and evaluation of the efficacy of polmacoxib in patients with osteoarthritis of hip/knee are the primary and secondary objectives, respectively. Assessment of treatment emergent clinical and laboratory adverse events (TEAEs) during the treatment period is the primary end point, which lasts for 6 weeks.
Secondary endpoints include change from baseline to week 6 in the WOMAC Total OA Index and subscale scores and change from baseline to week 6 in pain score measured by VAS scale,
Change from baseline to Week 6 in Subject’s Global Assessment (SGA), and Change from baseline to Week 6 in Physician’s Global Assessment (PGA). Total study duration per patient is 10 weeks, out of which 2 weeks are for screening, followed by 6 weeks of treatment, and another two more weeks for safety follow-up.