A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee

NCT02495857 | Completed Results

• 1 other identifier: AV01.2015-0863
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 26 weeks

Secondary Outcomes (2)

• 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

Study Arms (3)

Hyaluronate Injectable Viscosupplement

EXPERIMENTAL

Hyaluronate Injectable Viscosupplement (1% sodium hyaluronate). IA injection to the knee once weekly for 3 weeks

Device: Hyaluronate Injectable Viscosupplement

Euflexxa IA injection

ACTIVE COMPARATOR

Euflexxa IA injection to the knee once weekly for 3 weeks

Device: Euflexxa IA injection

Placebo

PLACEBO COMPARATOR

Placebo (normal saline). IA injection to the knee once weekly for 3 weeks

Device: Placebo

Interventions

Hyaluronate Injectable Viscosupplement DEVICE

Test product of a 1% sodium hyaluronate for injection

Also known as: 1% sodium hyaluronate

Hyaluronate Injectable Viscosupplement

Euflexxa IA injection DEVICE

Brand product of a 1% sodium hyaluronate for injection

Also known as: 1% sodium hyaluronate

Euflexxa IA injection

Placebo DEVICE

0.9% sodium chloride, sterile

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (2)

Mehra

San Diego, California, 92103, United States

Location

Bretton

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Senior Director, Clinical R&D
• Organization: Teva Pharmaceuticals Inc. USA

USMedinfo@tevapharm.com

1-888-483-8279

Study Officials

• Henry Lay, PhD

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 13, 2015
• Study Start: August 15, 2015
• Primary Completion: December 5, 2016
• Study Completion: December 5, 2016
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Locations

US (2)