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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
599

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hyaluronate Injectable Viscosupplement
Hyaluronate Injectable Viscosupplement (1% sodium hyaluronate). IA injection to the knee once weekly for 3 weeks
Device: Hyaluronate Injectable Viscosupplement
Test product of a 1% sodium hyaluronate for injection
Other Names:
  • 1% sodium hyaluronate
Active Comparator: Euflexxa IA injection
Euflexxa IA injection to the knee once weekly for 3 weeks
Device: Euflexxa IA injection
Brand product of a 1% sodium hyaluronate for injection
Other Names:
  • 1% sodium hyaluronate
Placebo Comparator: Placebo
Placebo (normal saline). IA injection to the knee once weekly for 3 weeks
Device: Placebo
0.9% sodium chloride, sterile
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actavis Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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