Meniscal TearPhase 3NCT01406561
Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
A Phase 3 study testing OMS103HP-S in people with Meniscal Tear, run by Omeros Corporation at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Meniscal Tear
- What is being tested?
- OMS103HP-S
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- In the opinion of the Investigator are able to comply with study-required visits and procedures
- 18 to 75 years of age, inclusive at the time of screening
- 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
- Planning to undergo unilateral arthroscopic meniscectomy
- 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
- 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.
Who cannot join
- Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren- Lawrence Grading Scale).
- History of reactive synovial disease
- 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
- History of fibromyalgia
- Expected to undergo any of the following procedures concurrent with the meniscectomy:
- Meniscal repair procedure
Show all 24Show fewer
- 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
- Known allergies to any of the individual ingredients in OMS103HP-S, other NSAIDs, aspirin, tricyclic antidepressants, or opioid analgesics
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Have a job-related claim(s) under dispute or mediation
- History of drug or alcohol abuse
- Treatment with an investigational drug or device within 30 days prior to the day of surgery
- 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
- Expected to receive a regional block for analgesia for this procedure
- Considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug
- 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 locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Orthopedic Surgery Center
Altoona, Pennsylvania, 16602
Orthopedic Surgery Center
Bloomington, Minnesota, 55431
Orthopedic Surgery Center
Chicago, Illinois, 60612
Orthopedic Surgery Center
Columbus, Ohio, 43221
Orthopedic Surgery Center
Durham, North Carolina, 27710
Orthopedic Surgery Center
Edina, Minnesota, 55435
Orthopedic Surgery Center
Encinitas, California, 92024
Orthopedic Surgery Center
Laguna Hills, California, 92653
Orthopedic Surgery Center
Los Angeles, California, 90045
Orthopedic Surgery Center
New York, New York, 10003
Orthopedic Surgery Center
Phoenix, Arizona, 85023
Orthopedic Surgery Center
Phoenix, Arizona, 85050
Orthopedic Surgery Center
Royal Oaks, Michigan, 48073
Orthopedic Surgery Center
San Antonio, Texas, 78229
Orthopedic Surgery Center
Seattle, Washington, 98122
Orthopedic Surgery Center
State College, Pennsylvania, 16801
Orthopedic Surgery Center
The Bronx, New York, 10461
Orthopedic Surgery Center
Tucson, Arizona, 85712
About this study
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
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.
- Conditions
- Meniscal Tear
- Being tested
- OMS103HP-S, Vehicle
- Keywords
- Meniscectomy, Knee Pain, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS103HP-SDrug
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
VehicleDrug
3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| OMS103HP-S | Experimental | OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery Receives: Drug: OMS103HP-S |
| Vehicle Irrigation Solution | Placebo comparator | Vehicle Irrigation Solution Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Symptoms Subscale
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.
Measured: 30 days
Safety
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.
Measured: 90 days
Secondary outcomes (6)
Knee Function in Sport Active patients
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.
Measured: 30 Days
Knee Pain
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.
Measured: 30 days
Quality of Life
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.
Measured: 30 days
Knee Function
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.
Measured: 30 days
Postoperative Knee Pain
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.
Measured: Day of Surgery (day 1)
Passive Flexion
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.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Whitaker, MD, Study director, Omeros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406561
- Sponsor's protocol ID
- OMS103-MEN-002
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2011
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01406561
- Acronym / sponsor ID
- OMS103-MEN-002
- Conditions
- Meniscal Tear
- Keywords
- Meniscectomy, Knee Pain, Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMS103HP-S | Experimental | Drug: OMS103HP-SOMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery |
| Vehicle Irrigation Solution | Placebo comparator | Drug: VehicleVehicle Irrigation Solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- In the opinion of the Investigator are able to comply with study-required visits and procedures
- 18 to 75 years of age, inclusive at the time of screening
- 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
- Planning to undergo unilateral arthroscopic meniscectomy
Key exclusion criteria (24 listed)
- Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren- Lawrence Grading Scale).
- History of reactive synovial disease
- 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
- History of fibromyalgia
- Expected to undergo any of the following procedures concurrent with the meniscectomy:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMS103HP-SProprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery | Drug | OMS103HP-S |
| Vehicle3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery | Drug | Vehicle Irrigation Solution |
Primary outcome
KOOS Symptoms Subscale
Time frame: 30 days
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
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.
6 secondary outcomes
Knee Function in Sport Active patients
Time frame: 30 Days
Knee Pain
Time frame: 30 days
Quality of Life
Time frame: 30 days
Knee Function
Time frame: 30 days
Postoperative Knee Pain
Time frame: Day of Surgery (day 1)
Passive Flexion
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Whitaker, MD study director
Omeros Corporation
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OMS103HP-S in people with Meniscal Tear, run by Omeros Corporation at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS Symptoms Subscale (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.