Clinical trial NCT00988091: Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee
Official title: A 26 Week, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Single Intra-Articular Injection 1.2% Sodium Hyaluronate for Treatment of Painful Osteoarthritis of the Knee, With Optional 26-Week Open-Label Safety Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 596
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26
timeFrame: Day 0 (baseline) through Week 26
Secondary outcomes:
measure: Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26
timeFrame: Day 0 (baseline), week 26
measure: Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.
timeFrame: Day 0 (baseline), Week 26
measure: Subjective Patient Assessment of Treatment at Week 26
timeFrame: Week 26
measure: Number of Tablets of Rescue Medication Used Between Visits
timeFrame: Day 1 to week 26
measure: Change From Baseline in Patient Global Assessment at Week 26
timeFrame: Day 0 (baseline), Week 26
measure: Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26
timeFrame: Day 0 (baseline), week 26
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Apex Clinical Trials, LLC
state: Alabama
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Hot Springs
country: United States
facility: St. Joseph's Mercy Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Rx Medical Research of Arkansas, Inc
state: Arkansas
city: Buena Park
country: United States
facility: Southbay Pharma Research
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: La Mesa
country: United States
facility: Triwest Research Associates
state: California
city: Los Angeles
country: United States
facility: UCLA-Division of Rheumatology
state: California
city: Santa Barbara
country: United States
facility: Investigational Site
state: California
city: Englewood
country: United States
facility: Colorado Arthritis Center, PC
state: Colorado
city: Wheatridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Trumball
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Aventura
country: United States
facility: International Physicians Research
state: Florida
city: Ft. Lauderdale
country: United States
facility: Investigational Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Leesburg
country: United States
facility: Tri-County Orthopaedic Center
state: Florida
city: Wellington
country: United States
facility: Clinical Research Center LLC
state: Florida
city: Winter Park
country: United States
facility: National Pain Research Institute, LLC
state: Florida
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Pinnacle Orthopaedics and Sports Medicine
state: Georgia
city: Shawnee
country: United States
facility: Lee Research Institute
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Passaic
country: United States
facility: New Jersey Physicians, LLC
state: New Jersey
city: Oklahoma City
country: United States
facility: Research Department, Bone & Joint Hospital at St. Anthony
state: Oklahoma
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Orthopedic & Spine Center
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: McKenzie
country: United States
facility: McKenzie Medical Center
state: Tennessee
city: Grapevine
country: United States
facility: Texas Orthopedic Specialists, PA
state: Texas
city: Houston
country: United States
facility: Memorial Bone & Joint Research Foundation
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials (DCT) - Stone Oak, LLC
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: