Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis Pain (DRAGON)
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Subject (female or male) 40-80 years of age, inclusive
- Documented diagnosis of mild to moderate osteoarthritis of the study knee that fulfil the ACR(American College of Rheumatology) criteria
- Radiographic evidence of osteoarthritis in the study knee (Kellgren Lawrence radiographic score is 2 or 3)
Exclusion Criteria:
- Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella
- Kellgren-Lawrence radiographic score 0, 1 or 4 in the study knee
- Symptomatic osteoarthritis of the contralateral knee or of either hip that is not responsive to acetaminophen/paracetamol and/or requires any protocol prohibited therapies
Sites / Locations
- Beijing Frienship Hospital
- Beijing General Military Hospital
- Beijing University #3 Hospital
- Beijing University People's Hospital
- Zhejiang #2 Hospital
- Shanghai #6 People's Hospital
- Shanghai #9 People's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
ARTZ sodium hyaluronate
DUROLANE hyaluronic acid
The comparator product, ARTZ, is manufactured by Seikagaku Corporation, Japan. Subjects randomized to the ARTZ group were administered five weekly intra-articular injections (2.5 ml, NASHA 25 mg). ARTZ is a sterile, viscoelastic nonpyrogenic solution of purified, high molecular weight (620,000-1,170,000 daltons) sodium hyaluronate having a pH of 6.8-7.8. The sodium hyaluronate is extracted from chicken combs.
The investigational product was provided in pre-filled syringes containing stabilized non-animal hyaluronic acid (20 mg/mL). Only one injection was given for those subjects randomized to the DUROLANE group, followed by 4 sham injections. DUROLANE is free from products of animal origin and is manufactured by Q-Med AB Corporation.The sham injection procedure was same as the active injection, except that they were subcutaneous and an empty syringe was used.