Different Volumes of Durolane in Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
Intervention description: Durolane is an intraarticular hyaluronic acid preparation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety and efficacy profiles of new
      single-injection volumes of Durolane in patients with knee OA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject (female or male)

          -  40-85 years of age

          -  Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for
             diagnosis of osteoarthritis(OA)

          -  Radiographic evidence of OA in the study knee

          -  WOMAC pain score of 7-17 in the study knee

          -  WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)

          -  Subject normally active

          -  Subject has attempted but not responded adequately to previous non-pharmacological
             therapy(ies)and to simple analgetics

          -  Subject cooperative and able to communicate effectively with the investigators

          -  Body mass index ≤ 35 kg/m2;

          -  Signed informed consent obtained

        Exclusion Criteria:

          -  Knee effusion

          -  Contralateral knee OA

          -  Clinically significant joint pain from joints other than the knee

          -  Previous intra-articular steroid injection into the study knee within the last 6
             months

          -  Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the
             last 9 months

          -  Previous allergic type reaction to a HA product

          -  Treatment with analgesics other than paracetamol (acetaminophen) (including topical
             agents for the knee) within 5 half lives of the drug prior to the baseline visit

          -  Use of analgesics 48 hours preceding the baseline visit

          -  Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3
             months

          -  Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months

          -  Change in physical therapy for the knee within the last three months

          -  Arthroscopy or other surgical procedure in the study knee within the past 12 months

          -  Serious injuries to the study knee in the past

          -  Any planned arthroscopy or other surgical procedure during the study period

          -  Previous history or presence of active septic arthritis

          -  Active skin disease or infection in the area of the injection site

          -  Systemic active inflammatory condition or infection

          -  Bleeding diathesis or use of anticoagulants

          -  History of drug or alcohol abuse within 6 months

          -  Any medical condition that in the opinion of the investigator makes the subject
             unsuitable for inclusion

          -  Pregnant or breastfeeding woman or woman of childbearing potential not practicing
             adequate contraception

          -  Involvement in other clinical trials