Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects with Osteoarthritis of the Knee

• Conditions: Osteoarthritis of the knee; MedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis

• Registration Number: EUCTR2006-006485-42-SE
• Lead Sponsor: Q-Med AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. Subject (female or male) 35-80 years of age, inclusive;
2. Unilateral knee pain fulfilling ACR criteria for diagnosis of OA (see Appendix 2), most days of the month, for three months;
3. Radiographic evidence of OA in the study knee (Kellgren-Lawrence radiographic score 2 or 3).40 X-rays obtained within 6 months prior to screening are acceptable;
4. WOMAC pain score of 7-17 in the study knee at both the screening and baseline visits;
5. Subject normally active, not bedridden or confined to a wheelchair, and able to walk 50 meters without the help of a walker, crutches, or a cane;
6. Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
7. Subject cooperative and able to communicate effectively with the investigators;
8. Body mass index (BMI) less than or equal to 40 kg/m2;
9. Signed informed consent obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A clinically detectable knee effusion (positive bulge sign or positive patellar tap);
2. Clinically significant contralateral knee OA as evidenced by a WOMAC pain score in this knee >3 (out of 20);
3. Clinically significant hip pain defined by the question, Have you suffered from pain in or around the hip in most days in the previous month?”;
4. Clinically significant joint pain from joints other than the knee or hip;
5. Previous intra-articular steroid injection into the study knee within the last 3 months;
6. Previous intra-articular HA injection into the study knee within the last 9 months;
7. Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
8. 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;
9. Use of opioids other than weak opioids (codeine up to 15 mg per tablet, propoxyphene, dextropropoxyphene) for OA pain on 3 or more days/week within the last month;
10. Use of paracetamol (acetaminophen) or any other analgesic during the 24 hours preceding the baseline visit;
11. Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
12. Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months, or dosage not stable for the past 3 months;
13. Change in physical therapy for the knee within the last three months, or expected change in physical therapy for the knee during the study,;
14. Serious injury to the study knee in the previous 6 months;
15. Arthroscopy or other surgical procedure in the study knee within the past 12 months;
16. Any planned arthroscopy or other surgical procedure during the study period;
17. Previous history or presence of active septic arthritis in the study knee;
18. Active skin disease or infection in the area of the injection site;
19. Systemic active inflammatory condition or infection, such as rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, gout/ acute pseudogout or any other connective tissue disease;
20. Bleeding diathesis or use of anticoagulants (except for acetylsalicylic acid maximum 325 mg/day);
21. Current uncontrolled diabetes mellitus;
22. Known history of drug or alcohol abuse within 6 months prior to screening;
23. Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia, significant venous or lymphatic stasis) or that, in the opinion of the investigator, are unsuitable for inclusion (e.g., subjects not likely to avoid other therapies, subjects not likely to stay in the study during the whole study period or likely to be unreliable);
24. Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
25. Involvement in other clinical trials that involve treatment or any other intervention within the 30 days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.;Secondary Objective: 1. If non-inferiority is established, to assess the superiority of Durolane to methylprednisolone.<br>2. To assess the safety and tolerability of Durolane compared to methylprednisolone in subjects with OA of the knee during the entire blinded phase.<br>3. To assess the efficacy of Durolane compared to methylprednisolone at 6 weeks, 18 weeks, and 26 weeks after injection.<br>;Primary end point(s): The primary efficacy endpoint will be the WOMAC pain score responder rate, defined as a greater than or equal to 40% and an absolute greater than or equal to 5 point improvement in the WOMAC pain score at 12 weeks following injection of study product at the baseline visit.