Different Volumes of Durolane in Knee OA

Launched by GALDERMA R&D · Dec 22, 2010

Keywords

ClinConnect Summary

To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.

Gender

ALL

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