Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Galderma R&D
- Enrollment
- 68
- Locations
- 3
- Primary Endpoint
- Change of Pain Over 26 Weeks (Change From Baseline)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
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
Outcomes
Primary Outcomes
Change of Pain Over 26 Weeks (Change From Baseline)
Time Frame: 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 Outcomes
- 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)
- WOMAC Stiffness Score (Change From Baseline)(26 weeks after treatment compared to baseline)
- WOMAC Physical Function Score (Change From Baseline)(26 weeks after treatment compared to baseline)
- Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)(26 weeks after treatment compared to baseline)