Last reviewed · How we verify
Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis. (ENKORE)
Clinical trial with medical device, multicenter, single-blind (blind third party evaluation), randomized, comparative and in two paralell groups, to demonstrate the treatment according to usual clinical practice, of the combination of 50 mg Sodium Hyaluronate and 50 mg Chondroitin Sulfate (ENKO 1) in a single administration, has non-inferiority efficacy vs the comparator (Durolane; 60 mg HA crosslinked) in patients with symptomatic knee osteoarthritis after three months of follow-up.
Details
| Lead sponsor | OPKO Health, Inc. |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 175 |
| Start date | Fri Dec 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri May 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Osteoarthritis, Knee
Interventions
- ENKO 1
- Durolane
Countries
Spain