Knee Osteoarthritis
Conditions
Keywords
Double-blind, Randomized, Intraarticular injection, Hyaluronic acid, Placebo, Knee osteoarthritis
Brief summary
The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) ≤ 35 kg/m2 * Symptomatic osteoarthritis (OA) of the knee * K L severity grade 1 or 2 * If bilateral OA, contralateral knee K L severity grade 0 or 1
Exclusion criteria
* Has clinically apparent tense effusion of the index knee * Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months * Has any painful orthopedic disorders of the back or hip * Has a joint disorder other than osteoarthritis in the index knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 | Up to 30 weeks | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Durolane Single intraarticular injection of Durolane
Durolane | 37 |
| Phosphate Buffered Saline (PBS) Single intraarticular injection of PBS
PBS | 38 |
| Total | 75 |
Baseline characteristics
| Characteristic | Durolane | Phosphate Buffered Saline (PBS) | Total |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 8.89 | 59.6 years STANDARD_DEVIATION 8.94 | 58.7 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 33 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 37 participants | 38 participants | 75 participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 37 | 0 / 38 |
| other Total, other adverse events | 15 / 37 | 13 / 38 |
| serious Total, serious adverse events | 2 / 37 | 1 / 38 |
Outcome results
Primary
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.
Time frame: Up to 30 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Durolane | Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 | -32.3 units on a scale | Standard Deviation 19.64 |
| Phosphate Buffered Saline (PBS) | Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 | -26.8 units on a scale | Standard Deviation 20.17 |