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Status:

COMPLETED

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

Lead Sponsor:

Biologische Heilmittel Heel GmbH

Conditions:

Osteoarthritis, Knee

Eligibility:

All Genders

45-80 years

Phase:

PHASE3

Brief Summary

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 osteoarthr...

Detailed Description

The primary objective is to demonstrate the superiority of Traumeel® and Zeel® co-administered intra-articular (IA) injections vs placebo IA injections on the change in knee pain in patients with mode...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Screening Visit 1):
  • Osteoarthritis (OA) of the knee by American College of Rheumatology criteria
  • Men or women between 45-80 years of age.
  • Have documented diagnosis of primary OA of the target knee based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment of the target knee confirmed by standard post-anterior weightbearing X-ray of the knee in full extension taken \</= 6 months prior to Visit 1.
  • Currently taking an Nonsteroidal anti-inflammatory drug (NSAID), or acetaminophen on a regular basis (4-7 days/ week) over last 2 weeks prior to Visit 1 and has experienced amelioration of pain on these medications.
  • Must have a 50-foot walk test pain score of less than 40 mm on a 100 mm VAS in the target knee at screening
  • Pain in the non-target (contralateral) knee must not be greater than 30 mm on a 100 mm VAS on 50-foot walk test, and the target knee must be more symptomatic.
  • Willingness to stop all OA treatments.
  • Fully informed of the risks of entering the study and willing to provide written consent to enter the study.
  • Able to understand and be willing to comply with all study requirements, particularly the weekly injection regimen for administration of study drug.
  • Primary complaint is pain immediately following an unassisted 50-foot walk. They must show:
  • moderate to severe pain score in the target knee as demonstrated by 40 - 90 mm recorded on a 100 mm VAS, and
  • 20 mm increase in pain from their screening visit pain score (a "flare")
  • pain in the non-target (contralateral) knee must \</= 30 mm on a 100 mm VAS
  • Exclusion Criteria:
  • 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
  • Therapy with opioids within the last 90 days including intra-dermal delivery systems (patches)
  • Therapy with autologous stem cells
  • Therapy with coumarins such as warfarin, Coumadin; heparin and derivative substances including low molecular weight heparin, synthetic pentasaccharide inhibitors of factor Xa such as fondaparinux and idraparinux; direct factor Xa inhibitors such as rivaroxaban and apixaban; direct thrombin inhibitors such as hirudin, lepirudin, bivalirudin, argatroban and dabigatran.
  • Concomitant inflammatory or other rheumatologic, neurological or cardiovascular diseases which could affect the evaluation of knee pain
  • Ongoing litigation for workers compensation for musculoskeletal injuries or disorders
  • Use of alcohol of more than 4 drinks per day
  • Clinically important axial deviation (varus, valgus) greater than 15 degrees
  • Concomitant severe OA of the hip or other joints, which might interfere with the assessments required by the study
  • Painful knee conditions other than OA (e.g., Paget's disease)
  • Hemiparesis of lower limbs
  • Significant planned surgery to lower limbs, which might interfere with the patient's ability to comply with study requirements
  • Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disease that might interfere with the outcome of the study or the patient's ability to comply with study requirements
  • Presence of infections and/or skin diseases in the area of the injection site such as psoriasis
  • Females who are pregnant or breast-feeding or not using recognized effective contraceptive measures. Females of childbearing potential (including those less than one year post-menopausal) must agree to maintain reliable birth control throughout the study.
  • Clinically significant abnormal laboratory values.
  • Patients who are likely to be non-compliant or uncooperative during the study.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2014

    Estimated Enrollment :

    287 Patients enrolled

    Trial Details

    Trial ID

    NCT01887678

    Start Date

    June 1 2013

    End Date

    January 1 2014

    Last Update

    April 2 2018

    Active Locations (30)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (30 locations)

    1

    Clinical Research Advantage - Arizona II

    Phoenix, Arizona, United States, 85050

    2

    Tucson Orthopaedic Institute

    Tucson, Arizona, United States, 85712

    3

    Universal BioPharma Research Inc.

    Dinuba, California, United States, 93618

    4

    Providence Clinical Research

    North Hollywood, California, United States, 91606