Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

Galderma

Status and phase

Completed

Phase 4

Conditions

Unilateral Knee Osteoarthritis

Treatments

Other: Saline injection

Device: Durolane injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01806207

35GA0301

Details and patient eligibility

About

This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.

Enrollment

218 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Osteoarthritis according to ACR (American College of Radiology) criteria for the knee
WOMAC pain score in the range 7 to 17
Significant knee pain for the majority of days during the past 3 months
Patient 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
Patient has attempted but not responded adequately to non-pharmacological therapy(ies)
Patient co-operative and able to communicate effectively with the investigators
Signed informed consent obtained

Exclusion criteria

Bilateral knee osteoarthritis
Osteoarthritis or clinically significant pain from other part of the musculoskeletal system than the study knee
Kellgren Lawrence radiographic score grade IV for the study knee
Change in physical therapy/occupational therapy for the knee within the last 3 months
Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents for the study knee) during the last week (or 5 half-lives of the drug, whichever is longer) prior to baseline visit
Treatment with non-NSAID topicals such as capsaicin for the knee within the last 3 days
Intra-articular injection with corticosteroids in the study knee within the last 3 months
Use of systemic steroids (excluding inhalation steroids) within the last 3 months
Intra-articular injections with hyaluronic acid in the study knee within the last 9 months
Treatment with glucosamine/chondroitin sulfate within the last 3 months
Treatment with pain relievers except for paracetamol up to 4g/day
Treatment with anticoagulant (except for acetylsalicylic acid max. 325 mg/day)
Arthroscopy or any other surgical procedure in the study knee within the last 12 months
Planned arthroscopy or any other surgical procedure during the study period
Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g. severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia)
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
Septic arthritis in the study knee within the last 3 months
Active skin disease or infection in the area of the injection site
Significant venous or lymphatic stasis present in the legs
Pregnant or breast-feeding woman or woman of child-bearing potential not practicing adequate contraception
Subjects 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 subjects likely to be unreliable)
Concurrent participation in any other clinical study or participation within the preceding 30 days