Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® / Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated with osteoarthritis of the knee.

Key facts

Study ID

NCT01887678

Run by

Biologische Heilmittel Heel GmbH

People needed

287

Starts

2013-06-01

Expected to finish

2014-01-01

Last updated by the study team

2018-04-02

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Known hypersensitivity or allergy to any of the components of Traumeel or Zeel
• Known hypersensitivity or allergy to acetaminophen.
• Has body mass index (BMI) >38 kg/m2.
• Avoidance of, or aversion to, nonprescription medications.
• Clinical symptoms of meniscal instability or significant valgus/ varus that requires corrective osteotomy
• Any major injury or surgery to the target knee in the prior 12 months.
• One or a combination of the following co-morbidities:
• other inflammatory arthropathies, gout or pseudogout within previous 6 months
• avascular necrosis
• severe bone or joint deformity in target knee
• osteonecrosis of either knee
• fibromyalgia
• pes anserine bursitis
• lumbar radiculopathy with referred pain to either knee
• neurogenic or vascular claudication
• significant anterior knee pain due to diagnosed isolated patella-femoral syndrome in the target knee
• target knee joint infection or skin disorder/infection to the area surrounding the knee within previous 6 months
• current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
• Participated in any experimental drug or device study within the prior one (1) month and/or IA injections six (6) months.
• Referred pain from other joints
• Significantly debilitating concurrent infection(s)
• Significant ligamentous instability
• Any prior viscosupplementation therapy (in target knee) within 6 months prior to Screening
• Systemic or IA injection of corticosteroids in any joint within 3 months of enrollment
• Therapy with oral hyaluronic acid products, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein

Where it is running

• Clinical Research Advantage - Arizona II — Phoenix, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• Universal BioPharma Research Inc. — Dinuba, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Hans Richard Barthel, M.D., Inc. — Santa Barbara, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Radiant Research Inc. - Denver — Denver, Colorado, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• AppleMed Research, Inc. — Miami, Florida, United States
• Radiant Research Inc. — Pinellas Park, Florida, United States
• Injury Care Medical Center — Boise, Idaho, United States
• Global Scientific Innovations — Evansville, Indiana, United States
• Sundance Clinical Research, LLC — St Louis, Missouri, United States
• Manhattan Medical Research — New York, New York, United States
• Research Across America - NY — New York, New York, United States
• PMG Cary Medical Research — Cary, North Carolina, United States
• New Hope Clinical Research — Charlotte, North Carolina, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• PMG Research of Raleigh — Raleigh, North Carolina, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• Radiant Research Inc. - Akron — Akron, Ohio, United States
• Sterling Research Group, Ltd — Cincinnati, Ohio, United States
• Clinical Inquest Center Ltd. — Dayton, Ohio, United States
• Hillcrest Clinical Research — Oklahoma City, Oklahoma, United States
• Blair Orthopedic Associates, Inc. — Altoona, Pennsylvania, United States

Full record on ClinicalTrials.gov

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