Trials / Completed
CompletedNCT01372475
Hymovis™ Versus Placebo in Knee Osteoarthritis
A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (actual)
- Sponsor
- Fidia Farmaceutici s.p.a. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline \[PBS\] in subjects with symptomatic osteoarthritis of the knee.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hymovis Intra-articular Injection | Hymovis Intra-articular injection |
| PROCEDURE | Phosphate Buffered Saline Injection | Placebo Intra-articular injection |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-11-01
- Completion
- 2013-02-01
- First posted
- 2011-06-14
- Last updated
- 2014-04-08
Locations
33 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01372475. Inclusion in this directory is not an endorsement.