Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis OA Arthritis pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 389
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28. arm 2: TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28. arm 3: Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.

Interventions: intervention 1: TV-45070 intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: