A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Actavis Inc.
- Enrollment
- 599
- Locations
- 2
- Primary Endpoint
- Change From Baseline in the WOMAC Pain Score in the Target Knee at Week 26 [Western Ontario and McMaster Universities Arthritis Index (WOMAC®)]
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of Investigational hyaluronate as compared to placebo injected into the target knee for the treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the investigational product will also be compared with Euflexxa.
Detailed Description
The primary objective is to evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of hyaluronate viscosupplement as compared to placebo injected into the target knee for the treatment of pain in subjects with OA As secondary objectives, the study will evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of Viscosupplement as compared to Euflexxa injected into the target knee for the treatment of pain in subjects with OA. In addition, to assess the effect of Viscosupplement on pain, stiffness, and physical function of the target knee, as well as functional health and general well-being
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic OA of target knee confirmed by American College of Rheumatology Criteria
- •Pain due to OA in target knee that had been present for at least 6 months, with a moderate to severe pain score of \>50 mm recorded on a 100 mm Visual Analogue Scale (VAS) following a 50-foot walk
- •Subject agrees to discontinue all pain medications for at least 7 days prior to start of study
- •A bilateral standing anteroposterior x-ray confirming Grade 2 or 3 OA of the target knee
- •Body mass index ≤40kg/m2
- •Able and willing to use only acetaminophen as the analgesic (rescue) study medication under the following conditions:
- •acetaminophen dose is not to exceed 4 grams (4000mg)/day
- •if the subject has known chronic liver disease, the maximum dose of acetaminophen is not to exceed 2 grams (2000 mg)/day
- •subject must be able and willing to discontinue acetaminophen at least 24 hours prior to all study-specific visits
- •Ability to perform procedures required of the pain index evaluations (unassisted walking for a distance of 50 feet on a flat surface and going up and down stairs)
Exclusion Criteria
- •Any major injury to the target knee within the 12 months prior to the Screening and Enrollment Visit
- •Any surgery to the target knee within the 12 months prior to the Screening and Enrollment Visit,
- •Articular procedures such as transplants or ligament reconstruction to the target knee within 12 months prior to Screening and Enrollment Visit
- •Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
- •Gout or calcium pyrophosphate diseases of the target knee that have flared within the 6 months prior to the Screening and Enrollment Visit
- •X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
- •Osteonecrosis of either knee
- •Clinical signs and symptoms of active knee infection or crystal disease of the target knee
- •Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
- •Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee
Outcomes
Primary Outcomes
Change From Baseline in the WOMAC Pain Score in the Target Knee at Week 26 [Western Ontario and McMaster Universities Arthritis Index (WOMAC®)]
Time Frame: Baseline and 26 weeks
The primary effectiveness endpoint was the change from Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) pain score in the target knee at Week 26.The validated WOMAC was used to assess pain, stiffness, and physical function of the target knee.The range of pain score was 0 to 500 mm with higher scores for worse pain.
Secondary Outcomes
- Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26(26 weeks)
- Change in Stiffness of the Knee After 26 Weeks as Measured by the WOMAC Pain Score in the Target Knee at Week 26 [Western Ontario and McMaster Universities Arthritis Index (WOMAC®)](26 weeks)