Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
NCT ID: NCT01406561
Last Updated: 2018-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
344 participants
INTERVENTIONAL
2011-08-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OMS103HP-S
OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery
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
Vehicle Irrigation Solution
Vehicle Irrigation Solution
Vehicle
3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery
Interventions
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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
Vehicle
3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery
Eligibility Criteria
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Inclusion Criteria
2. In the opinion of the Investigator are able to comply with study-required visits and procedures
3. 18 to 75 years of age, inclusive at the time of screening
4. Have a traumatic or degenerative meniscal cartilage injury (full thickness tear) that occurred at least 14 days prior to the day of arthroscopic surgery that is demonstrated on MRI
5. Planning to undergo unilateral arthroscopic meniscectomy
6. If female and of childbearing potential (i.e., not surgically sterilized or post-menopausal for longer than one year), agree to use a medically accepted method of birth control for the duration of her study involvement
7. At minimal risk from anesthesia and classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 (a normal healthy patient) or PS-2 (a patient with mild systemic disease that results in no functional limitation) as determined by the Investigator.
Exclusion Criteria
2. History of reactive synovial disease
3. History of a 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 sensory deficit of the lower extremities
4. History of fibromyalgia
5. Expected to undergo any of the following procedures concurrent with the meniscectomy:
* Meniscal repair procedure
* Patellar tendon debridement
* Patellar realignment
* Lateral or retinacular release
* Excision synovectomy (minor synovectomy to improve arthroscopic visualization is allowed)
* Concurrent ligamentous procedure
* Abrasion chondroplasty involving bone
* Microfracture
* Chondral transplantation
* Use of more than three portals
6. Known allergies to any of the individual ingredients in OMS103HP-S, other NSAIDs, aspirin, tricyclic antidepressants, or opioid analgesics
7. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
8. Have a job-related claim(s) under dispute or mediation
9. History of drug or alcohol abuse
10. Treatment with an investigational drug or device within 30 days prior to the day of surgery
11. A clinically significant medical condition that in the opinion of the Investigator would put the subject at increased risk, impair the subject's ability to comply with the requirements of the protocol, or confound the interpretation of the data
12. Expected to receive a regional block for analgesia for this procedure
13. Considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug
14. The Investigator, employee of the investigative site, and/or part of the Investigator/employee's immediate families (defined as current spouse or partner, parent, natural or legally adopted child, stepchild living in the household, grandparent, or grandchild).
18 Years
75 Years
ALL
No
Sponsors
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Omeros Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Steve Whitaker, MD
Role: STUDY_DIRECTOR
Omeros Corporation
Locations
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Orthopedic Surgery Center
Phoenix, Arizona, United States
Orthopedic Surgery Center
Phoenix, Arizona, United States
Orthopedic Surgery Center
Tucson, Arizona, United States
Orthopedic Surgery Center
Encinitas, California, United States
Orthopedic Surgery Center
Laguna Hills, California, United States
Orthopedic Surgery Center
Los Angeles, California, United States
Orthopedic Surgery Center
Chicago, Illinois, United States
Orthopedic Surgery Center
Royal Oaks, Michigan, United States
Orthopedic Surgery Center
Bloomington, Minnesota, United States
Orthopedic Surgery Center
Edina, Minnesota, United States
Orthopedic Surgery Center
New York, New York, United States
Orthopedic Surgery Center
The Bronx, New York, United States
Orthopedic Surgery Center
Durham, North Carolina, United States
Orthopedic Surgery Center
Columbus, Ohio, United States
Orthopedic Surgery Center
Altoona, Pennsylvania, United States
Orthopedic Surgery Center
State College, Pennsylvania, United States
Orthopedic Surgery Center
San Antonio, Texas, United States
Orthopedic Surgery Center
Seattle, Washington, United States
Countries
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Other Identifiers
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OMS103-MEN-002
Identifier Type: -
Identifier Source: org_study_id
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