OsteoarthritisNCT02495857
A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
A study testing Hyaluronate Injectable Viscosupplement and Euflexxa IA injection in people with Osteoarthritis, run by Actavis Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hyaluronate Injectable Viscosupplement and Euflexxa IA injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 599 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2015to 5 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bretton
Albuquerque, New Mexico, 87102
Mehra
San Diego, California, 92103
About this study
Official title: 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.
Read the 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
- Conditions
- Osteoarthritis
- Being tested
- Hyaluronate Injectable Viscosupplement, Euflexxa IA injection, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronate Injectable ViscosupplementDevice
Also called 1% sodium hyaluronate
Test product of a 1% sodium hyaluronate for injection
Euflexxa IA injectionDevice
Also called 1% sodium hyaluronate
Brand product of a 1% sodium hyaluronate for injection
PlaceboDevice
Also called Normal saline
0.9% sodium chloride, sterile
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronate Injectable Viscosupplement | Experimental | Hyaluronate Injectable Viscosupplement (1% sodium hyaluronate). IA injection to the knee once weekly for 3 weeks Receives: Device: Hyaluronate Injectable Viscosupplement |
| Euflexxa IA injection | Active comparator | Euflexxa IA injection to the knee once weekly for 3 weeks Receives: Device: Euflexxa IA injection |
| Placebo | Placebo comparator | Placebo (normal saline). IA injection to the knee once weekly for 3 weeks Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the WOMAC Pain Score in the Target Knee at Week 26 [Western Ontario and McMaster Universities Arthritis Index (WOMAC®)]
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.
Measured: Baseline and 26 weeks
Secondary outcomes (2)
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
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.
Measured: 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®)]
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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study start15 Aug 2015
- Primary completion5 Dec 2016
- Study completion5 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Lay, PhD, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495857
- Sponsor's protocol ID
- AV01.2015-0863
- Status last verified
- Jun 2020
- First submitted
- 9 Jul 2015
- Last updated
- 23 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02495857
- Acronym / sponsor ID
- AV01.2015-0863
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Posted 23 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronate Injectable Viscosupplement | Experimental | Device: Hyaluronate Injectable ViscosupplementHyaluronate Injectable Viscosupplement (1% sodium hyaluronate). IA injection to the knee once weekly for 3 weeks |
| Euflexxa IA injection | Active comparator | Device: Euflexxa IA injectionEuflexxa IA injection to the knee once weekly for 3 weeks |
| Placebo | Placebo comparator | Device: PlaceboPlacebo (normal saline). IA injection to the knee once weekly for 3 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronate Injectable ViscosupplementAlso: 1% sodium hyaluronateTest product of a 1% sodium hyaluronate for injection | Device | Hyaluronate Injectable Viscosupplement |
| Euflexxa IA injectionAlso: 1% sodium hyaluronateBrand product of a 1% sodium hyaluronate for injection | Device | Euflexxa IA injection |
| PlaceboAlso: Normal saline0.9% sodium chloride, sterile | Device | Placebo |
Primary outcome
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.
2 secondary outcomes
Change in Pain Over Time From Baseline to Week 1, Week 6, Week 12 and Week 26
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Lay, PhD study director
Actavis Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronate Injectable Viscosupplement and Euflexxa IA injection in people with Osteoarthritis, run by Actavis Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.