Trials / Completed
CompletedNCT01406561
Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (actual)
- Sponsor
- Omeros Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the effect of OMS103HP solution for Injection (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS) Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms in subjects undergoing meniscectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OMS103HP-S | Proprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery |
| DRUG | Vehicle | 3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-11-01
- Completion
- 2012-12-01
- First posted
- 2011-08-01
- Last updated
- 2018-10-26
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01406561. Inclusion in this directory is not an endorsement.