A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: TV-45070; Placebo
Intervention description: TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.; Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 389.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis; OA; Arthritis pain

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
    

Eligibility 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