Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Diclofenac Sodium Topical Gel, 1%: Apply 4 gram of Gel to the affected area of target knee four times daily for 4 weeks (28 days).
Control Intervention1: Gel vehicle of test product: Ap
Sponsors
KLM Laboratories Pvt. Ltd.
Ms G SEVEN SYNERGON PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant, non-lactating female aged 35 years and older with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology criteria, including i.e., Knee pain along with at least 3 of the following 6 criteria a. Age more than 50 years b. Stiffness less than 30 minutes c. Presence of crepitus d. Bony tenderness e. Bony enlargement f. No palpable warmth. 2. Subject with symptoms in target knee for at least 6 months prior to screening. 3. Subjects with knee (not referred) pain in the target knee for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.). 4. Subject with pain in the target knee required the use of Nonsteroidal Anti-Inflammatory Drugs (NSAID) or acetaminophen (paracetamol) (topical or oral treatments). 5. Subject has X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of osteoarthritis with Kellgren-Lawrence Grade 1-3 disease. 6. After discontinuing all pain medications (placebo run – in period) for at least 7 days, subject has at least moderate Pain on Movement (POM) for target knee, defined as a baseline score of = 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization. 7. After discontinuing all pain medications (placebo run - in period) for at least 7 days subject has baseline Western and Ontario McMaster Universities Osteoarthritis Index (WOMAC Likert) pain subscale of = 9 immediately prior to randomization. 8. Subject who is able to tolerate rescue medication with only acetaminophen (paracetamol) taken as l-2 tablets up to a maximum of 2 gram per day for the duration of the study. 9. Able to replace all current pain medications with acetaminophen for use as needed during the duration of the study [subjects should be able to withhold all rescue medication (e.g., acetaminophen) use for at least 24 hours prior to all WOMAC pain sub scale score assessments at study visits]. 10. Subject who can read and understand WOMAC pain sub scale. 11.Female Subject of child bearing potential practicing an approved method of contraception and willing to continue its use from study entry to till the application of Investigational Product and have a negative Urine Pregnancy Test at the time of screening or Female Subjects of non-child bearing potential. 12.Male Subject must use accepted methods of birth control or must agree to practice abstinence from study entry to till the application of Investigational Product. 13.Willing to provide written informed consent. 14.Willing and able to comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1. Female subject who is pregnant, lactating, or who wish to become pregnant during the study period. 2. X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease. 3. After discontinuing all pain medications (placebo run-in period) for at least 7 days, had a baseline score of more than or equal to 20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization. 4. Subjects with BMI more than 40 kg/m2. 5. History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening. 6. History of OA of either Hip or Hands. 7. History of secondary OA (e.g., congenital, traumatic, gouty arthritis) or rheumatoid arthritis. 8. History of chronic inflammatory disease (e.g., colitis) or fibromyalgia. 9. History of drugs or alcohol abuse with in the previous year. 10.History of regular headaches or backache which warrants frequent use of acetaminophen (paracetamol) or NSAIDs within the previous year. 11.History of 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). 12.History of aspirin sensitive asthma. 13.History of uncontrolled hypertension (blood pressure more than 150/100 mm of Hg) in spite of treatment with in the previous year and/or any other clinically significant vital sign abnormality. 14.History of uncontrolled diabetes mellitus (HbA1C more than 8%). 15.History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function (Serum creatinine more than 1.5 x ULN), or liver disease with in the previous year. 16.History of coronary artery bypass graft within 6 months of screening. 17.History of gastrointestinal bleeding or peptic ulcer disease in last one year. 18.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. 19.Known history of positive HIV, HCV or HBsAg. 20.Known allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol). 21.Symptomatic peripheral vascular disease of the study leg (prior or current). 22.Concomitant skin disease at the application site which may affect study drug application or tolerability evaluation. 23.Elevated transaminases (morethan or equal to 3 times ULN) and haemoglobin less than 9.0 g/dL at screening. 24.Use of viscosupplementation in any joint including the target knee within 6 months prior to screening. 25.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening. 26.Concomitant use of intra articular corticosteroids, systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening. 27.Concomitant use of acetylsalicylic acid therapy other than a stable low dose for cardiac prophylaxis (maximum 162 mg daily) taken for at least 3 months prior to enrolment and maintained throughout the duration of the study. 28.Tense effusion requiring aspiration. 29.Subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score for the target kneeTimepoint: Day 0 and Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in pain on movement (POM) on a Visual Analog Scale (VAS) for the target kneeTimepoint: Day 0 and Day 29 | — |
Countries
India
Contacts
Public ContactDr D Sathish Kumar
G7 Synergon Private Limited
Outcome results
None listed