Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT01406561
First received: July 28, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Meniscal Tear
Drug: OMS103HP-S
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • KOOS Symptoms Subscale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  • Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    To evaluate the safety of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on safety as measured by adverse events.


Secondary Outcome Measures:
  • Knee Function in Sport Active patients [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee function as measured by the KOOS Sports and Recreation subscale through Day 30 in the subset of subjects who participate in sports.

  • Knee Pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee pain as measured by the KOOS Pain subscale through Day 30.

  • Quality of Life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee quality of life as measured by the KOOS Quality of Life subscale through Day 30.

  • Knee Function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee function as measured by the KOOS Activites of Daily Living subscale through Day 30.

  • Postoperative Knee Pain [ Time Frame: Day of Surgery (day 1) ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on postoperative knee pain as measured by the Visual Analog Scale during the day of surgery.

  • Passive Flexion [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on Passive flexion on Day 7.


Enrollment: 344
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMS103HP-S
OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery
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
Placebo Comparator: Vehicle Irrigation Solution
Vehicle Irrigation Solution
Drug: Vehicle
3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406561

Locations
United States, Arizona
Orthopedic Surgery Center
Phoenix, Arizona, United States, 85023
Orthopedic Surgery Center
Phoenix, Arizona, United States, 85050
Orthopedic Surgery Center
Tucson, Arizona, United States, 85712
United States, California
Orthopedic Surgery Center
Encinitas, California, United States, 92024
Orthopedic Surgery Center
Laguna Hills, California, United States, 92653
Orthopedic Surgery Center
Los Angeles, California, United States, 90045
United States, Illinois
Orthopedic Surgery Center
Chicago, Illinois, United States, 60612
United States, Michigan
Orthopedic Surgery Center
Royal Oaks, Michigan, United States, 48073
United States, Minnesota
Orthopedic Surgery Center
Bloomington, Minnesota, United States, 55431
Orthopedic Surgery Center
Edina, Minnesota, United States, 55435
United States, New York
Orthopedic Surgery Center
Bronx, New York, United States, 10461
Orthopedic Surgery Center
New York, New York, United States, 10003
United States, North Carolina
Orthopedic Surgery Center
Durham, North Carolina, United States, 27710
United States, Ohio
Orthopedic Surgery Center
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Orthopedic Surgery Center
Altoona, Pennsylvania, United States, 16602
Orthopedic Surgery Center
State College, Pennsylvania, United States, 16801
United States, Texas
Orthopedic Surgery Center
San Antonio, Texas, United States, 78229
United States, Washington
Orthopedic Surgery Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Omeros Corporation
Investigators
Study Director: Steve Whitaker, MD Omeros Corporation
  More Information

No publications provided

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT01406561     History of Changes
Other Study ID Numbers: OMS103-MEN-002
Study First Received: July 28, 2011
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Omeros Corporation:
Meniscectomy
Knee Pain
Postoperative Pain

ClinicalTrials.gov processed this record on July 23, 2014