Clinical trial NCT01406561: Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meniscal Tear
Keywords: Meniscectomy
Knee Pain
Postoperative Pain
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily provide written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable)
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:

1. Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren- Lawrence Grading Scale).
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).

Primary outcomes:
measure: KOOS Symptoms Subscale
timeFrame: 30 days
measure: Safety
timeFrame: 90 days
Secondary outcomes:
measure: Knee Function in Sport Active patients
timeFrame: 30 Days
measure: Knee Pain
timeFrame: 30 days
measure: Quality of Life
timeFrame: 30 days
measure: Knee Function
timeFrame: 30 days
measure: Postoperative Knee Pain
timeFrame: Day of Surgery (day 1)
measure: Passive Flexion
timeFrame: 7 Days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Orthopedic Surgery Center
state: Arizona
city: Phoenix
country: United States
facility: Orthopedic Surgery Center
state: Arizona
city: Tucson
country: United States
facility: Orthopedic Surgery Center
state: Arizona
city: Encinitas
country: United States
facility: Orthopedic Surgery Center
state: California
city: Laguna Hills
country: United States
facility: Orthopedic Surgery Center
state: California
city: Los Angeles
country: United States
facility: Orthopedic Surgery Center
state: California
city: Chicago
country: United States
facility: Orthopedic Surgery Center
state: Illinois
city: Royal Oaks
country: United States
facility: Orthopedic Surgery Center
state: Michigan
city: Bloomington
country: United States
facility: Orthopedic Surgery Center
state: Minnesota
city: Edina
country: United States
facility: Orthopedic Surgery Center
state: Minnesota
city: Bronx
country: United States
facility: Orthopedic Surgery Center
state: New York
city: New York
country: United States
facility: Orthopedic Surgery Center
state: New York
city: Durham
country: United States
facility: Orthopedic Surgery Center
state: North Carolina
city: Columbus
country: United States
facility: Orthopedic Surgery Center
state: Ohio
city: Altoona
country: United States
facility: Orthopedic Surgery Center
state: Pennsylvania
city: State College
country: United States
facility: Orthopedic Surgery Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Orthopedic Surgery Center
state: Texas
city: Seattle
country: United States
facility: Orthopedic Surgery Center
state: Washington
Study officials:
affiliation: Omeros Corporation
name: Steve Whitaker, MD
role: STUDY_DIRECTOR
References: