Different Volumes of Durolane in Knee OA

Galderma

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Study type: Interventional

Funder types: Industry

Identifiers

NCT01265459

35GA1001

Details and patient eligibility

About

The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.

Full description

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.

Enrollment: 68 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 3 patient groups

Durolane 3ml

Experimental group

Description:

Durolane 3 ml is an Intraarticular hyaluronic acid

Treatment:

Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Durolane 4.5

Experimental group

Description:

Durolane 4.5 is an Intraarticular hyaluronic acid

Treatment:

Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Durolane 6 ml

Experimental group

Description:

Durolane 6 ml is an Intraarticular hyaluronic acid

Treatment:

Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml