Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amneal Pharmaceuticals, LLC
• Collaborator: Sristek Clinical Research Solutions Limited
• Treatments: Diclofenac

Criteria

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