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The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMS103HP | Drug | Maximum 6 bags of OMS103HP irrigation solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the mean VAS at 24 hours postoperatively. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Subject with significant arthritis (>2 on the Kellgren-Lawrence Scale).
Subject with a history of reactive synovial disease.
Subject with current, or history of, complex regional pain syndrome (Type I, i.e., reflex sympathetic dystrophy, or Type II, i.e., causalgia), chronic pain, attendance at a chronic pain clinic, or neurologic disorder associated with any sensory deficit of the lower extremities.
Subject with current, or history of fibromyalgia.
Subject taking ANY ANALGESIC (including salicylates, opioids, propoxyphene, etc.) on the day of surgery from 12:00 A.M. until after the procedure, except for medications authorized by the Investigator or delegated staff.
Subject taking any of the following medications within the stated time frames prior to the day of surgery.
Subject expected to undergo any of the following procedures concurrent with meniscectomy:
Subject with allergies to any of the individual ingredients in OMS103HP, to related compounds (e.g., other NSAIDs or tricyclic antidepressants), or to opioid analgesics.
Subject who is pregnant or breast-feeding.
Subject with Worker's Compensation claim(s) under dispute or mediation.
Subject with history of drug or alcohol abuse.
Subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.
Subject with a history or presence of systemic disease (renal, hepatic, psychiatric, etc.), which in the opinion of the Medical Monitor and the Principal Investigator, may place the subject's health at risk by participation in the study.
Subject who is expected to receive a regional block for analgesia for this procedure.
Subject who is considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Houston | Omeros Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| Visions Clinical Research |
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| Vehicle |
| Drug |
Maximum of 6 bags of vehicle irrigation solution |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Kerlan-Jobe Orthopaedic Clinic - Westchester | Los Angeles | California | 90045 | United States |
| Advanced Orthopedic and Sports Medicine Specialists | Aurora | Colorado | 80014 | United States |
| Colorado Orthopedic Consultants | Englewood | Colorado | 80110 | United States |
| Greater Chesapeake Orthopaedic Associates | Baltimore | Maryland | 21218 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Unlimited Research | San Antonio | Texas | 78217 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C530310 | OMS 103HP |
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