Trials / Completed
CompletedNCT03762408
Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis.
Comparative Study of the Efficacy and Safety of an Intra-articular Injection of ENKO 1 vs Durolane in Patients With Symptomatic Osteoarthritis of the Knee.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- OPKO Health, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ENKO 1 | 50 mg of HA/ 50 mg of CS in 5 ml |
| DEVICE | Durolane | 60 mg HA crosslinked in 3 ml |
Timeline
- Start date
- 2017-12-15
- Primary completion
- 2020-05-29
- Completion
- 2020-05-29
- First posted
- 2018-12-03
- Last updated
- 2021-03-23
Locations
18 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT03762408. Inclusion in this directory is not an endorsement.