Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee

NCT ID: NCT00988091

Last Updated: 2012-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 596 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-04-30

Brief Summary

Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IA-SA

Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.

Group Type: PLACEBO_COMPARATOR

Buffered Saline

Intervention Type: DEVICE

IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.

IA-BioHA

Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.

Group Type: EXPERIMENTAL

1.2% Sodium Hyaluronate

Intervention Type: DEVICE

IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).

Interventions

1.2% Sodium Hyaluronate

IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).

Intervention Type: DEVICE

Buffered Saline

IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.

Intervention Type: DEVICE

Other Intervention Names

sodium hyaluronate; saline

Eligibility Criteria

Inclusion Criteria

• Chronic osteoarthritis (OA) of target knee confirmed by American College of Rheumatology (ACR) Criteria.
• Pain due to OA in target knee present for at least 6 months.
• During Screening and Baseline visits, subjects will require a visual analog scale (VAS) score (100 mm) of ≥ 41 mm and ≤ 90 mm, recorded immediately following a 50-foot walk, AND at Baseline, cannot have decreased >10mm (improvement) from Screening.
• A bilateral standing anteroposterior (AP) X-ray confirming OA of the target knee.
• Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
• Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs).
• Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions.
• Signed Subject Informed Consent Form

Exclusion Criteria

• Any major injury (including sports injuries) to the target knee within the prior 12 months.
• Any surgery to the target knee, hip and contralateral hip within the prior 12 months.
• Major and minor articular procedures
• Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis.
• Gout or calcium pyrophosphate (pseudogout) diseases of the target knee that have flared within the previous 6 months.
• 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.
• 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 previous 6 months prior to study enrollment.
• Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee.
• Known hypersensitivity to acetaminophen, sodium hyaluronate, or phosphate buffered saline solution.
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.
• Recurrent medical history of 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.
• Current treatment or treatment within the previous 2 years prior to Screening for any malignancy unless specific written permission is provided by the Sponsor (excluding basal cell or squamous cell carcinoma of the skin).
• Chronic liver disease and active liver disease based on liver profile of aspartate aminotransferase (AST), alanine transaminase (ALT), and conjugated bilirubin >2 times the upper limit of normal.
• Renal insufficiency based on serum creatinine >2.0 mg/dL.
• Any clinically significant laboratory value based on clinical history that the Investigator feels may affect the study evaluation.
• Any intercurrent chronic disease or condition that may interfere with the completion of the 6-month (or 12-month) follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition.
• Current alcoholism, and/or any known current addiction to pain medications.
• Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study.
• Any psychiatric illness that would prevent comprehension of the details and nature of the study.
• Participation in any experimental device study within 6 months prior to the Screening, or an experimental drug study within 1 month prior to the Screening

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Apex Clinical Trials, LLC

Homewood, Alabama, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

St. Joseph's Mercy Clinic

Hot Springs, Arkansas, United States

Rx Medical Research of Arkansas, Inc

Little Rock, Arkansas, United States

Southbay Pharma Research

Buena Park, California, United States

Providence Clinical Research

Burbank, California, United States

Triwest Research Associates

La Mesa, California, United States

UCLA-Division of Rheumatology

Los Angeles, California, United States

Investigational Site

Santa Barbara, California, United States

Colorado Arthritis Center, PC

Englewood, Colorado, United States

Front Range Clinical Research

Wheat Ridge, Colorado, United States

New England Research Associates, LLC

Trumball, Connecticut, United States

International Physicians Research

Aventura, Florida, United States

Investigational Site

Fort Lauderdale, Florida, United States

Sunrise Medical Research

Lauderdale Lakes, Florida, United States

Tri-County Orthopaedic Center

Leesburg, Florida, United States

Clinical Research Center LLC

Wellington, Florida, United States

National Pain Research Institute, LLC

Winter Park, Florida, United States

Georgia Institute for Clinical Research

Marietta, Georgia, United States

Pinnacle Orthopaedics and Sports Medicine

Marietta, Georgia, United States

Lee Research Institute

Shawnee, Kansas, United States

Professional Research Network of Kansas

Wichita, Kansas, United States

New Jersey Physicians, LLC

Passaic, New Jersey, United States

Research Department, Bone & Joint Hospital at St. Anthony

Oklahoma City, Oklahoma, United States

Omega Medical Research

Warwick, Rhode Island, United States

Palmetto Medical Research

Mt. Pleasant, South Carolina, United States

Palmetto Clinical Trial Services, LLC

Simpsonville, South Carolina, United States

Black Hills Orthopedic & Spine Center

Rapid City, South Dakota, United States

Holston Medical Group

Kingsport, Tennessee, United States

McKenzie Medical Center

McKenzie, Tennessee, United States

Texas Orthopedic Specialists, PA

Grapevine, Texas, United States

Memorial Bone & Joint Research Foundation

Houston, Texas, United States

Discovery Clinical Trials (DCT) - Stone Oak, LLC

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Countries

United States

Other Identifiers

2009-03

Identifier Type: -

Identifier Source: org_study_id