Clinical Study to Evaluate the Bioequivalence using Clinical Endpoint of Diclofenac Sodium Topical Gel, 1% in Subjects with Osteoarthritis (OA) of the Knee.
- Conditions
- Health Condition 1: null- Osteoarthritis (OA) of the Knee
- Registration Number
- CTRI/2018/06/014519
- Lead Sponsor
- Encube Ethicals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1116
1.Healthy male or non-pregnant female aged more than to equal to 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria2 i.e. Knee pain along with at least 3 of the following 6 criteria
a.Age > 50 years
b.Stiffness less than 30 minutes
c.Presence of crepitus
d.Bony tenderness
e.Bony enlargement
f.No palpable warmth
2.Symptoms in target knee for at least 6 months prior to screening
3.Knee (not referred) pain in 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.Pain in the target knee requiring the use of NSAIDs or acetaminophen (paracetamol) (topical or oral treatments).
5.Subject 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.
6.After discontinuing all pain medications (placebo run â?? in period) for at least 7 days, has at least moderate pain on movement (POM) for target knee, defined as a baseline score of more than or equal to 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization.
7.After discontinuing all pain medications (placebo run â?? in period) for at least 7 days has a baseline Western and Ontario McMaster Universities Osteoarthritis Index (WOMAC Likert) pain subscale of more than or equal to 9 immediately prior to randomization.
8.Able to tolerate rescue medication with only acetaminophen (paracetamol) taken as l-2 tablets up to a maximum of 2 gm per day for the duration of the study.
9.Subjects who can read and understand WOMAC pain sub scale.
10.Able to give written informed consent to participate in the study.
11.Male subjects and Female subjects of childbearing potential agree to use accepted methods of birth control including abstinence, from study start to 7 days after the last application of study drug.
1.Pregnant or lactating or planning to become pregnant during the study period.
2.X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
3.History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening.
4.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.
5.History of OA of either Hip or Hands.
6.History of secondary OA (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
7.History of chronic inflammatory disease (e.g., colitis) or fibromyalgia.
8.History of drugs or alcohol abuse with in the previous year.
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 which warrants frequent use of acetaminophen (paracetamol) or NSAIDs within the previous year.
12.Concomitant skin disease at the application site which 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 aspirin sensitive asthma.
15.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.
16.History of uncontrolled diabetes mellitus (HbA1C greater than 8 percent).
17.Subjects with BMI more than 40 kg/m2.
18.History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function (Serum creatinine greater than 1.5 x ULN), or liver disease with in the previous year.
19.History of coronary artery bypass graft within 6 months of screening.
20.History of gastrointestinal bleeding or peptic ulcer disease in last one year.
21.Known allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
22.Elevated transaminases (greater than or equal to 3 times ULN) and hemoglobin less than 9.0 g/dL at screening.
23.Viscosupplementation in any joint including the target knee within 6 months prior to screening.
24.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
25.Concomitant use of intra articular corticosteroids, systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
26.Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (maximum 162 mg daily)3 taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
27.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.
28.Known history of positive HIV, HC
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Mean change in the total WOMAC pain subscale score for the target kneeTimepoint: from baseline to week 4
- Secondary Outcome Measures
Name Time Method â?¢Mean change in pain on movement (POM) on a Visual Analog Scale (VAS) for target kneeTimepoint: from baseline to week 4