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

Omeros

Status and phase: Completed; Phase 3

Conditions: Meniscal Tear

Treatments: Drug: OMS103HP-S; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406561

OMS103-MEN-002

Details and patient eligibility

About

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.

Enrollment: 344 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

344 participants in 2 patient groups, including a placebo group

OMS103HP-S

Experimental group

Description:

OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery

Treatment:

Drug: OMS103HP-S

Vehicle Irrigation Solution

Placebo Comparator group

Description:

Vehicle Irrigation Solution

Treatment:

Drug: Vehicle