- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495857
A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
June 9, 2020 updated by: Actavis Inc.
A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
599
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- Mehra
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- Bretton
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
- Agrees to use a highly effective contraception
- Able and willing to complete effectiveness and safety questionnaires and able to read and understand study instructions
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
- Significant target knee joint, infection or skin disorder infection within the 6 months prior to study enrollment
- Symptomatic OA of the hips, spine, or ankle, that interferes with the evaluation of the target knee
- Known hypersensitivity to acetaminophen or any of the study medications or their components
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant
- History of recurrent severe allergic or immune mediated reactions or other immune disorders
- Vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation
- Intra-arterial corticosteroid (investigational or marketed) in any joint within 3 months of Screening and Enrollment Visit
- Current treatment, or treatment within the 2 years prior to the Screening and Enrollment Visit, for any malignancy
- Active liver disease based on liver profile of aspartate aminotransferase, alanine aminotransferase, and conjugated bilirubin >2 times the upper limit of normal
- Renal insufficiency based on serum creatinine >2.0mg/dL
- Any intercurrent chronic disease or condition that might interfere with the completion of the study
- Current alcoholism and/or any known current addiction to pain medications
- Participation in any experimental device study within 6 months prior to the Screening and Enrollment Visit, or participation in an experimental drug study within 1 month prior to the Screening and Enrollment Visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyaluronate Injectable Viscosupplement
Hyaluronate Injectable Viscosupplement (1% sodium hyaluronate).
IA injection to the knee once weekly for 3 weeks
|
Test product of a 1% sodium hyaluronate for injection
Other Names:
|
Active Comparator: Euflexxa IA injection
Euflexxa IA injection to the knee once weekly for 3 weeks
|
Brand product of a 1% sodium hyaluronate for injection
Other Names:
|
Placebo Comparator: Placebo
Placebo (normal saline).
IA injection to the knee once weekly for 3 weeks
|
0.9% sodium chloride, sterile
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
Time Frame: 26 weeks
|
The change from Baseline in the WOMAC pain score over time (baseline to Week 1, Week 6, Week 12 and Week 26) using Western Ontario and McMaster Universities Arthritis Index (WOMAC®)].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.
|
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®)]
Time Frame: 26 weeks
|
The change from baseline in the stiffness 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 stiffness score was 0 to 100 mm with higher scores for worse stiffness.
|
26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Henry Lay, PhD, Actavis Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2015
Primary Completion (Actual)
December 5, 2016
Study Completion (Actual)
December 5, 2016
Study Registration Dates
First Submitted
July 9, 2015
First Submitted That Met QC Criteria
July 10, 2015
First Posted (Estimate)
July 13, 2015
Study Record Updates
Last Update Posted (Actual)
June 23, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AV01.2015-0863
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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