Trials / Completed
CompletedNCT01934218
Gel-One Treatment in Knee Osteoarthritis
A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 814 (actual)
- Sponsor
- Seikagaku Corporation · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gel-One | |
| DEVICE | PBS |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-09-04
- Last updated
- 2023-03-23
- Results posted
- 2017-07-02
Locations
41 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01934218. Inclusion in this directory is not an endorsement.