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.
Brief Title
Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
Completion Date
Completion Date Type
Actual
Conditions
Meniscal Tear
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).
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).
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Meniscectomy
Knee Pain
Postoperative Pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT01406561
Org Class
Industry
Org Full Name
Omeros Corporation
Org Study Id
OMS103-MEN-002
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
KOOS Symptoms Subscale
Outcome Time Frame
30 days
Outcome Description
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.
Outcome Measure
Safety
Outcome Time Frame
90 days
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
30 Days
Outcome Measure
Knee Function in Sport Active patients
Outcome Description
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.
Outcome Time Frame
30 days
Outcome Measure
Knee Pain
Outcome Description
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.
Outcome Time Frame
30 days
Outcome Measure
Quality of Life
Outcome Description
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 Activities of Daily Living subscale through Day 30.
Outcome Time Frame
30 days
Outcome Measure
Knee Function
Outcome Description
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.
Outcome Time Frame
Day of Surgery (day 1)
Outcome Measure
Postoperative Knee Pain
Outcome Description
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.
Outcome Time Frame
7 Days
Outcome Measure
Passive Flexion
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tony Wanich
Investigator Email
twanich@montefiore.org
Investigator Phone