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NCT01406561 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
A Phase 3 study, sponsored by Omeros Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 344
- Enrollment target
NCT01406561: Completed Phase 3 study, sponsored by Omeros Corporation.
NCT01406561 is a Phase 3 study that has completed, run by Omeros Corporation. The registered enrollment target is 344 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01406561, a Phase 3 study, has completed, sponsored by Omeros Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 344 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee symptoms as measured by the KOOS Symptoms subscale through Day 30.
Interventions
- DRUG Vehicle
- DRUG OMS103HP-S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01406561 record still lists
NCT01406561 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01406561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01406561 about?
NCT01406561 is a clinical study titled "Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy". 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...
What is the current status of trial NCT01406561?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 344 participants. The study started on 2011-08. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01406561?
The interventions under investigation include: Vehicle (DRUG), OMS103HP-S (DRUG).
Who is sponsoring clinical trial NCT01406561?
This trial is sponsored by Omeros Corporation, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01406561's enrollment target sits among peer trials
344 1050th of 2000 higher than 950 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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