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 Study
A Randomized, Open Label, Active-Controlled, Multicentre, Prospective, Comparative, Phase III 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
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CR/CT/18/009
Protocol Number
Dated: Dec 24, 2018, Version No. 02
Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sudheer Tulasi
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
rimsresearch@gmail.com
Details of Contact Person Scientific 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.
New Delhi DELHI 110087 India
Phone
9811882440
Fax
Email
dra@synokempharma.com
Details of Contact 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.
New Delhi DELHI 110087 India
Phone
9811882440
Fax
Email
dra@synokempharma.com
Source of Monetary or Material Support
Synokem Pharmaceuticals Ltd.
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
Primary Sponsor
Name
Synokem Pharmaceuticals Ltd
Address
Synokem Pharmaceuticals Ltd.
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
Institutional Ethics Committee, Sparsh Hospital and Critical Care
Submittted/Under Review
Redkar Hospital Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Oxaceprol Capsules 200 mg
One Capsule orally three times daily for 6 weeks
Intervention
Oxaceprol SR Tablets 600 mg
One Tablet orally once daily for 6 weeks
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.
ExclusionCriteria
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 Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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 visit 1, visit 2, visit 3, visit 4 and visit 5
Secondary Outcome
Outcome
TimePoints
Improvement in Subject’s and Physician’s Global Assessment of Osteoarthritis
At visit 1, visit 3, visit 4 and visit 5
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "219" Final Enrollment numbers achieved (India)="219"