Osteoarthritis | Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Osteoarthritis research study
What is the primary objective of this study?
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.
Who is eligible to participate?
Inclusion Criteria: - Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee. - 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. - After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee - If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study - Able to tolerate rescue medication with paracetamol/acetaminophen. Exclusion Criteria: - Pregnant or lactating or planning to become pregnant during the study period. - X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease. - History of OA pain in the contralateral knee requiring medication within 1 year prior to screening. - 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. - History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia. - History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. - History of gastrointestinal bleeding or peptic ulcer disease. - Use of warfarin or other anticoagulant therapy within 30 days of study randomization. - Elevated transaminases at screening. - Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization. - Concomitant use of corticosteroids or use within 30 days of study randomization. - Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study. - Known allergy to aspirin or nonsteroidal anti-inflammatory drug - Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study. - Receipt of any drug as part of a research study within 30 days prior to screening. - Previous participation in this study. - Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs). - Recent history of major knee injury or surgery. - Known history of positive HIV
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Diclofenac Sodium Topical Gel, 1%Opaque, white gel
Drug:Voltaren Topical Gel, 1%Opaque, white gel
Drug:Vehicle Diclofenac Sodium Topical GelOpaque, white gel
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren Topical Gel, 1%Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical GelVehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Start Date: April 2014
Completed Date: December 2014
Phase: Phase 3
Primary Outcome: WOMAC Pain Score
Study sponsors, principal investigator, and references
Principal Investigator: Prayag Shah, MD
Lead Sponsor: Amneal Pharmaceuticals, LLC
Collaborator: Sristek Clinical Research Solutions Limited