Health Condition 1: null- Patients with osteoarthritis of the knee
Conditions
Interventions
Intervention1: Generic
Diclofenac Sodium Topical Gel
: It is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such
Sponsors
Amneal Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study. 2.Healthy, ambulatory male or non-pregnant female subjects aged >= 35 years with a clinical diagnosis of OA of the knee including: •Presence of at least three (3) of the American College of Rheumatology (ACR) criteria (age >= 50; stiffness lasting •Symptoms for at least 6 months prior to screening, AND •Knee (not referred) pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.), AND •The pain in the target knee required the use of NSAIDs or paracetamol/ acetaminophen (topical or oral treatments). 3.Had 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. 4.After discontinuing all pain medications for at least 7 days, 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, AND a baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of at least 9 immediately prior to randomization. 5.If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives). 6.Able to tolerate rescue medication with paracetamol/acetaminophen. 7.Willing and able to comply with the study requirements.
Exclusion criteria
Exclusion criteria: 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 for at least 7 days, has a baseline score of >= 20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization. 5.History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia. 6.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. 7.History of gastrointestinal bleeding or peptic ulcer disease. 8.Use of warfarin or other anticoagulant therapy within 30 days of study randomization. 9.Elevated transaminases at screening (AST or ALT more than 2 times the upper limit of normal at screening visit). 10.Use of ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within 30 days of study randomization. 11.Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization. 12.Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study. 13.Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID). 14.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study. 15.Receipt of any drug as part of a research study within 30 days prior to screening. 16.Previous participation in this study. 17.Any use between screening and baseline of a treatment or medication that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs). 18.Recent history of major knee injury or surgery. 19.Known history of positive HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the mean change from baseline to week 4 in the WOMAC pain scoreTimepoint: Assessment of WOMAC scale from Day 1 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| not applicableTimepoint: not applicable | — |
Countries
India
Contacts
Public ContactIrshadulHaque
Amneal Pharmaceuticals
Outcome results
None listed