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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Placebo; Drug: TV-45070

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068599

TV-45070-CNS-20005

Details and patient eligibility

About

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

Enrollment: 389 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

389 participants in 3 patient groups, including a placebo group

TV-45070 4%

Experimental group

Description:

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.

Treatment:

Drug: TV-45070

TV-45070 8%

Experimental group

Description:

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.

Treatment:

Drug: TV-45070

Placebo

Placebo Comparator group

Description:

Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.

Treatment:

Drug: Placebo