A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Branded Pharmaceutical Products R&D, Inc.
Age
40–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
