Durolane Versus Methylprednisolone in Knee Osteoarthritis

Galderma

Status and phase

Completed

Phase 3

Conditions

Knee Osteoarthritis

Treatments

Device: Durolane is a device, methylprednisolone in a drug

Study type

Interventional

Funder types

Industry

Identifiers

NCT01209364

35GA0608

Details and patient eligibility

About

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 pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Enrollment

442 patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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 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