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

NCT00988091 | Completed Phase 3 Results

• 1 other identifier: 2009-03
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 34

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26

  The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.

  Day 0 (baseline) through Week 26

Secondary Outcomes (6)

• Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26

  Day 0 (baseline), week 26

• Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.

  Day 0 (baseline), Week 26

• Subjective Patient Assessment of Treatment at Week 26

  Week 26

• Number of Tablets of Rescue Medication Used Between Visits

  Day 1 to week 26

• Change From Baseline in Patient Global Assessment at Week 26

  Day 0 (baseline), Week 26

Study Arms (2)

IA-SA

PLACEBO COMPARATOR

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.

Device: Buffered Saline

IA-BioHA

EXPERIMENTAL

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.

Device: 1.2% Sodium Hyaluronate

Interventions

1.2% Sodium Hyaluronate 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).

Also known as: sodium hyaluronate

IA-BioHA

Buffered Saline 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.

Also known as: saline

IA-SA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (34)

Apex Clinical Trials, LLC

Homewood, Alabama, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Location

St. Joseph's Mercy Clinic

Hot Springs, Arkansas, United States

Location

Rx Medical Research of Arkansas, Inc

Little Rock, Arkansas, United States

Location

Southbay Pharma Research

Buena Park, California, United States

Location

Providence Clinical Research

Burbank, California, United States

Location

Triwest Research Associates

La Mesa, California, United States

Location

UCLA-Division of Rheumatology

Los Angeles, California, United States

Location

Investigational Site

Santa Barbara, California, United States

Location

Colorado Arthritis Center, PC

Englewood, Colorado, United States

Location

Front Range Clinical Research

Wheat Ridge, Colorado, United States

Location

New England Research Associates, LLC

Trumball, Connecticut, United States

Location

International Physicians Research

Aventura, Florida, United States

Location

Investigational Site

Fort Lauderdale, Florida, United States

Location

Sunrise Medical Research

Lauderdale Lakes, Florida, United States

Location

Tri-County Orthopaedic Center

Leesburg, Florida, United States

Location

Clinical Research Center LLC

Wellington, Florida, United States

Location

National Pain Research Institute, LLC

Winter Park, Florida, United States

Location

Georgia Institute for Clinical Research

Marietta, Georgia, United States

Location

Pinnacle Orthopaedics and Sports Medicine

Marietta, Georgia, United States

Location

Lee Research Institute

Shawnee, Kansas, United States

Location

Professional Research Network of Kansas

Wichita, Kansas, United States

Location

New Jersey Physicians, LLC

Passaic, New Jersey, United States

Location

Research Department, Bone & Joint Hospital at St. Anthony

Oklahoma City, Oklahoma, United States

Location

Omega Medical Research

Warwick, Rhode Island, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, United States

Location

Palmetto Clinical Trial Services, LLC

Simpsonville, South Carolina, United States

Location

Black Hills Orthopedic & Spine Center

Rapid City, South Dakota, United States

Location

Holston Medical Group

Kingsport, Tennessee, United States

Location

McKenzie Medical Center

McKenzie, Tennessee, United States

Location

Texas Orthopedic Specialists, PA

Grapevine, Texas, United States

Location

Memorial Bone & Joint Research Foundation

Houston, Texas, United States

Location

Discovery Clinical Trials (DCT) - Stone Oak, LLC

San Antonio, Texas, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 1, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 15, 2012
• Results First Posted: June 4, 2012

Record last verified: 2012-06

Locations

US (34)