A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee

• Status: Completed
• Trial end date: 2015-05-04
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.

Criteria

Inclusion Criteria:

• Patient is between 40 and 85 years of age, Patient has primary OA in a single knee (target knee) confirmed by American College of Rheumatology criteria.

• For patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics at the time of the screening visit,

• Patient has visual analog scale (VAS) pain scores with acceptable ranges as determined by the investigator during screening

• Except for OA, patient is judged by the investigator to be medically healthy and able to participate in the study.

• Other criteria apply, please contact the investigator for additional information

Exclusion Criteria:

• Patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (RA), gout, other primary bone disease, or acute trauma.

• Patient has symptomatic chondrocalcinosis

• Patient has a history of fibromyalgia.

• Patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.

• Patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.

• Patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.

• Patient has a history of total or partial knee replacement in either leg.

• Patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.

• Patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of OA pain.

• Patient is intolerant to study drug, its excipients, and/or acetaminophen.

• Patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.

• Other criteria apply, please contact the investigator for additional information