Different Volumes of Durolane in Knee OA

Phase 2

Completed

Conditions: Knee Osteoarthritis

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

Registration Number: NCT01265459

Lead Sponsor: Galderma R&D

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durolane 4.5	Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml	Durolane 4.5 is an Intraarticular hyaluronic acid
Durolane 3ml	Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml	Durolane 3 ml is an Intraarticular hyaluronic acid
Durolane 6 ml	Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml	Durolane 6 ml is an Intraarticular hyaluronic acid

Primary Outcome Measures

Name	Time	Method
Change of Pain Over 26 Weeks (Change From Baseline)	26 weeks after treatment compared to baseline	The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.	From baseline to 26 weeks after treatment	Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?".
WOMAC Stiffness Score (Change From Baseline)	26 weeks after treatment compared to baseline	The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
WOMAC Physical Function Score (Change From Baseline)	26 weeks after treatment compared to baseline	The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)	26 weeks after treatment compared to baseline	The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from "very poor=0" to "excellent=10".