Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 19:14:42 GMT)

PDF of Trial CTRI Website URL - http://ctri.nic.in

CTRI Number CTRI/2019/04/018689 [Registered on: 22/04/2019] - Trial Registered Prospectively Last Modified On 18/10/2019 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 Trial to study the effect of Oxaceprol SR Tablets for the treatment of patients with Osteoarthritis Scientific Title of A Randomized, Open Label, Active-Controlled, Multicentre, Prospective, Comparative, Phase III Study Clinical study to assess the Efficacy, Safety and Tolerability of Oxaceprol SR Tablets 600 mg Once daily with Oxaceprol Capsules 200 mg Three times daily for the treatment of patients with Osteoarthritis Secondary IDs if Any Secondary ID Identifier CR/CT/18/009 Protocol Number Dated: Dec 24, 2018, Version No. 02 Other Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sudheer Tulasi Trial Coordinator (multi-center study) Designation Asst. Professor Affiliation Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital Address Department of Orthopaedics, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srikakulam Srikakulam ANDHRA PRADESH 532001 India Phone 8942279033 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Abhinav Arora Query) Designation Managing Director Affiliation Synokem Pharmaceuticals Ltd. Address Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. New Delhi DELHI 110087 India Phone 9811882440 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Abhinav Arora Designation Managing Director Affiliation Synokem Pharmaceuticals Ltd. Address Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India.

page 1 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in

New Delhi DELHI 110087 India Phone 9811882440 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. Primary Sponsor Primary Sponsor Details Name Synokem Pharmaceuticals Ltd Address Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sachin Dhote Central India Institute of Plot No. 14/2, Park 9823343626 Haematology and Corner, Balraj Marg, Oncology Near Lokmat Sq., [email protected] Dhantoli, m Nagpur-440012. Nagpur MAHARASHTRA Dr Pranab Kumar Down Town Hospital Down Town Hospital, 8486664152 Chowdhury Dispur, G S Road, Guwahati-781006 pranabioc2002@gmail. Kamrup com ASSAM Dr Bhanoth Valya Gandhi Hospital In Patient Block, 1st 9000357799 Floor, Department of Orthopaedics, Gandhi [email protected] Hospital, Musheerabad, Secunderabad-500003 Hyderabad TELANGANA Dr Patel Jyotish GCS Medical College, Opp. DRM Office, Nr. 9925038375 Girishchandra Hospital and Research Chamunda Bridge, Centre Naroda Road, [email protected] Ahmedabad - 380025 Ahmadabad GUJARAT Dr Rohit Nath GSVM Medical College Department of 8009984893 Orthopaedics, GSVM Medical College, [email protected] Swaroop Nagar, Kanpur-208002 Kanpur Nagar UTTAR PRADESH Dr Ritesh Runu Indira Gandhi Institute Department of 9572109488

page 2 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in

of Medical Sciences Orthopaedics, Indira Gandhi Institute of [email protected] Medical Sciences, m Sheikhpura, Patna-800014 Patna BIHAR Dr Jyoti Ranjan Parida Institute of Medical SOA University, K8, 9556980101 Sciences (IMS) and Kalinga Nagar, SUM Hospital Bhubaneswar-751003 [email protected] Khordha ORISSA Dr Arnab Karmakar Institute of Post IPGME & R, SSKM 9830401377 Graduate Medical Hospital, 244, Acharya Education & Research Jagadish Chandra Bose [email protected] Road, Kolkata-700020 m Kolkata WEST BENGAL Dr P Ashok Kumar King George Hospital Andhra Medical 9849123602 College, Visakhapatnam-530002 ashok_ortho59@rediffm . ail.com Visakhapatnam ANDHRA PRADESH Dr Vikalp Vashishitha Maharaja Agrasen Maharaja Agrasen 9829113330 Superspeciality Hospital Superspeciality Hospital, Central Spine, vikalpvashishtha@gmai Agrasen Aspatal Marg, l.com Sector-7, Vidyadhar Nagar, Jaipur-302039 Jaipur RAJASTHAN Dr Sudheer Tulasi Rajiv Gandhi Institute of Department of 8942279033 Medical Sciences & Orthopaedics, Rajiv RIMS Government Gandhi Institute of [email protected] Genera! Hospital Medical Sciences & m RIMS Government Genera! Hospital, Srikakulam-532001 Srikakulam ANDHRA PRADESH Dr Dattaraj K Nasnolkar Redkar Hospital and Redkar Hospital and 9158592177 Research Centre Research Centre, Mumbai-Goa Highway, [email protected] Oxelbag, Village-Dhargal, Tal-Pernem-403513, Goa, India North Goa GOA Dr Ranajit Panigrahi Sparsh Hospital & A/407, Saheed Nagar, 9777037435 Critical Care Bhubaneshwar-751007 Khordha ranajitpanigrahi@gmail. ORISSA com Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee, Approved 23/05/2019 No Down Town Hospital

page 3 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in

Ethics Committee, Approved 29/03/2019 No G.S.V.M Medical College Ethics Committee, Rajiv Approved 21/02/2019 No Gandhi Institute of Medical Sciences & RIMS Government Genera! Hospital Institutional Ethics Submittted/Under No Date Specified No Committee, Central Review India Institute of Haematology and Oncology Institutional Ethics Approved 29/03/2019 No Committee, Gandhi Medical College/Gandhi Hospital Institutional Ethics Approved 03/06/2019 No Committee, GCS Medical College, Hospital and Research Centre Institutional Ethics Approved 18/04/2019 No Committee, Indira Gandhi Institute of Medical Sciences Institutional Ethics Submittted/Under No Date Specified No Committee, Institute of Review Medical Sciences (IMS) and SUM Hospital Institutional Ethics Submittted/Under No Date Specified No Committee, IPGME&R, Review SSKM Hospital Institutional Ethics Submittted/Under No Date Specified No Committee, King Review George Hospital Institutional Ethics Approved 29/05/2019 No Committee, Maharaja Agrasen Superspecialty Hospital Institutional Ethics Submittted/Under No Date Specified No Committee, Sparsh Review Hospital and Critical Care Redkar Hospital Approved 12/04/2019 No Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Approved/Obtained 15/02/2019 Health Condition / Health Type Condition Problems Studied Patients Osteoarthritis of knee, unspecified Intervention / Type Name Details Comparator Agent Intervention Oxaceprol SR Tablets 600 mg One Tablet orally once daily for 6 weeks Comparator Agent Oxaceprol Capsules 200 mg One Capsule orally three times

page 4 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in

daily for 6 weeks Inclusion Criteria Inclusion Criteria Age From 30.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1. Male or female subjects, aged ?30 years to ?65 years at the time of informed consent.
2. Clinically diagnosed with sign and symptoms of Osteoarthritis of Knee.
3. Patient having grade 1-3 in Osteoarthritis condition according to Kellgren and Lawrence grading scale.
4. Knee pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min or knee crepitus.
5. Knee pain on movement of intensity at least 40 mm or above on a 100 mm VAS (Visual Analogue Score) scale.
Exclusion Criteria Exclusion Criteria Details 1. Pregnant or nursing women. 2. Patients having inflammatory arthritis, gout, pseudogout, Paget’s disease or any chronic pain syndrome that may interfere with assessment of the knee. 3. Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months. 4. Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrolment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at any time. 5. Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year. 6. Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrolment of a particular subject into the trial. 7. History of bleeding tendencies, cirrhosis and oesophageal varices. 8. Hypersensitive to Oxaceprol. 9. History of hypersensitivity or allergy to NSAIDs, other COX-2 inhibitors and/or sulphonamides. 10. Pre-existing asthma. 11. Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti-epileptics, fluconazole (inhibitor of CYP 2C9/3A4), ketoconazole (a known inhibitor of CYP 3A4) etc. 12. Immuno compromised states and patients with systemic infections. 13. Conditions predisposing to gastrointestinal dysfunction (e.g., history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.). 14. Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, collagen disorders, etc. or any other serious medical illness.

Method of Generating Computer generated randomization Random Sequence Method of Pharmacy-controlled Randomization Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Improvement in Western Ontario and McMasters At visit 1, visit 2, visit 3, visit 4 and visit 5

page 5 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in

(WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function).

Improvement in Visual Analog Scale (VAS).

Secondary Outcome Outcome Timepoints Improvement in Subject’s and Physician’s At visit 1, visit 3, visit 4 and visit 5 Global Assessment of Osteoarthritis Target Sample Size Total Sample Size=200 Sample Size from India=200 Final Enrollment numbers achieved (Total)=219 Final Enrollment numbers achieved (India)=219 Phase of Trial Phase 3 Date of First 25/04/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details NIL Brief Summary

This is a randomized, open label, active-controlled, multicentre, prospective, comparative, phase III clinical study. Study will enroll 200 patients with osteoarthritis from the different centers in India.

Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting all inclusion & none of the exclusion criteria) in 1:1 ratio to receive either Oxaceprol SR Tablets 600 mg once daily or Oxaceprol Capsules 200 mg three times daily for six weeks. The primary efficacy endpoint of the study is improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function) & improvement in Visual Analog Scale (VAS) at the end of treatment. Secondary efficacy endpoint include improvement in Subject’s and Physician’s Global Assessment of Osteoarthritis. During the study, there will be 5 study visits for efficacy, safety and tolerability assessment.

page 6 / 6