Status:
COMPLETED
Durolane Versus Methylprednisolone in Knee Osteoarthritis
Lead Sponsor:
Galderma R&D
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
The primary objective is 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 p...
Eligibility Criteria
Inclusion
- Subject (female or male) 35-80 years of age
- Unilateral knee pain
- Radiographic evidence of OA
- WOMAC pain score of 7-17
- Subject normally active
- Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
- Subject cooperative and able to communicate effectively with the investigators;
- Body mass index ≤ 40 kg/m2;
- Signed informed consent obtained.
Exclusion
- 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 3 months;
- Previous intra-articular HA injection into the study knee within the last 9 months;
- Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
- 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 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;
- 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
- Current uncontrolled diabetes mellitus;
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT01209364
Start Date
March 1 2007
End Date
November 1 2008
Last Update
August 25 2022
Active Locations (23)
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1
Alberta Bone & Joint Health Institute
Calgary, Alberta, Canada, T2P 3C5
2
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
3
Orthopaedic & Sport Medicine Institute of Nova Scotia
Halifax, Nova Scotia, Canada, B3H 4M2
4
Dr. Wilson
Lunenburg, Nova Scotia, Canada, B0J2C0