Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Diclofenac Diethylamine Gel 1.16%: The interventional product will be assigned to Each subject and will be instructed to
apply approximately 4 g to the target knee, four times a day for
Sponsors
Encube Ethical Private Limited, India
JSS Medical Research Asia Pacific Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males or non-pregnant, non-lactating females aged = 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology criteria, i.e. Knee pain along with at least 3 of the following 6 criteria (Appendix I) Age > 50 years Stiffness Presence of crepitus Bony tenderness Bony enlargement No palpable warmth 2. Symptoms in the target knee for at least 6 months prior to screening 3. Knee pain for 15 days of the preceding month (periarticular knee pain due to osteoarthritis and not due to other conditions such as bursitis, tendonitis, etc.) 4. The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAID) 5.Patients having an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease (Appendix no. II) Note: If a digital x-ray (both anterior-posterior and lateral view) of the target knee taken no more than 1 year before baseline is available then the findings of the available x-ray will be considered for evaluation and no repeat x-ray will be performed. 6. After discontinuation of all pain medications for at least 7 days (Placebo run-in period), have found at least moderate pain on movement (POM) for the target knee, defined as a baseline. score of = 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization (Appendix III) 7. After discontinuation of all pain medications for at least 7 days (Placebo run-in period), a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert, Version 3.1) pain subscale of = 9 immediately prior to randomization (Appendix IV) 8. Able to replace all current pain medications with acetaminophen for use as needed during the duration of the study [subject should be able to withhold all rescue medication (e.g., acetaminophen) use for at least 48 hours prior to all WOMAC pain score assessments at study. visits 9. Change in the total WOMAC pain subscale score for the target knee = 2 from Visit 2 (Start of Placebo Run-in period) to Visit 3 (Baseline/Randomization). 10. Subjects who can read and understand the WOMAC pain sub-scale. 11. Patients who are able to understand the investigational nature of this study and able to provide a written informed consent form 12. Patients who are willing and able to comply with all the study assessments and adhere to the protocol schedule 13. If female, the patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing the following methods of birth control: o Oral Contraceptives or Intrauterine Devices in place for at least 3 months prior to the start of the study and remaining in place during the study period, or o Double Barrier methods containing or used in conjunction with a spermicidal agent, or o Contraceptive Patches/ Implants, or o Abstinence: Subjects who will be practicing abstinence will agree to have a documented second acceptable method of birth control if the subject becomes sexually active during the course of her study particip
Exclusion criteria
Exclusion criteria: 1. Known history or presence of hypersensitivity or allergic reaction to Diclofenac, aspirin, acetaminophen, or other NSAIDs, or any other inactive ingredients used in the study product 2. Females who are pregnant or lactating or planning to become pregnant during the study period 3. The X-ray confirmed Kellgren-Lawrence Grade 4 disease of Osteoarthritis 4. History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening 5. After discontinuation of all pain medications for at least 7 days (Placebo run-in period), had a baseline score of = 20 mm on a 0-100 mm VAS for the contralateral knee immediately prior to randomization 6. History of OA of either Hip or Hands. 7. History or presence of secondary OA (e.g. Congenital, traumatic, gouty arthritis), rheumatoid arthritis 8. History or presence of chronic inflammatory disease (e.g. colitis) or fibromyalgia 9. Symptomatic peripheral vascular disease of the study leg (prior or current). 10. Any musculoskeletal condition that would impede measurement of efficacy at the target knee 11. History of regular headaches or backache or condition that warrants frequent use of acetaminophen (paracetamol) or NSAIDs within the previous year. 12. Concomitant skin disease at the application site may affect study drug application or tolerability evaluation. 13. History of active asthma within the previous year that may require periodic treatment with systemic steroids during the study period (note: inhaled steroids for this condition are allowed). 14. History of uncontrolled hypertension (blood pressure more than 150/100 mm of Hg) in spite of treatment within the previous year and/or any other clinically significant vital sign abnormality. 15. History of aspirin-sensitive asthma 16. History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function (Serum creatinine > 1.5 x ULN), or liver disease within 1 year of randomization 17. History of gastrointestinal bleeding or peptic ulcer disease in the last year 18. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past month prior to entry into the study 19. Elevated transaminases (= 3 times ULN) and hemoglobin 20. Concomitant use of intra-articular corticosteroids, systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening 21. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (maximum 162 mg daily) was taken for at least 3 months prior to enrolment and maintained throughout the duration of the study. 22. History of major surgery or previous damage to the study knee at any time, or minor knee surgery (e.g. any surgery other than major surgery including, but not limited to, cartilage repair, collateral ligament repair, or arthroscopic debridement) to the study knee within 1 year prior to screening 23. Visco-supplementation in any joint including the target knee within 6 months prior to screening. 24. Tense effusion requiring aspiration. 25. Known history of positive serology test i.e., HIV, HC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in the total WOMAC pain subscale score for the target knee.Timepoint: Visit 3 (Baseline Visit) (Day 0), Visit 5 (End of Treatment Visit) (Day 28± 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the total WOMAC pain subscale score for the target knee. Mean change in pain on movement (POM) on a Visual Analog Scale (VAS) for the target knee. Percentage of responders: A responder is defined as patients having a decrease of 2 or more points on the total WOMAC Pain Subscale score. The average number of days of acetaminophen (paracetamol) consumed during the trial.Timepoint: Visit 3 (Baseline Visit) (Day 0), Visit 4 (Interim Visit) (Day 14± 2) Visit 3 (Baseline Visit) (Day 0), Visit 5 (End of Treatment Visit) (Day 28± 4) Visit 3 (Baseline Visit) (Day 0), Visit 5 (End of Treatment Visit) (Day 28± 4) Visit 3 (Baseline Visit) (Day 0), Visit 4 (Interim Visit) (Day 14± 2), ), Visit 5 (End of Treatment Visit) (Day 28± 4) | — |
Countries
India
Contacts
Public ContactDr Neeraj Prasad
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed