Anterior Cruciate Ligament ReconstructionPhase 3NCT00245271
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
A Phase 3 study testing OMS103HP in people with Anterior Cruciate Ligament Reconstruction, run by Omeros Corporation at 10 sites in United States.
Trial summary
OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- OMS103HP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2004to Mar 2011
- 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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 17 - 65 years of age
- In good general health
- Undergoing arthroscopic ACL reconstruction for an ACL tear
Who cannot join
- Allergies to any of the individual ingredients in OMS103HP
- Has open physes in the distal femur or proximal tibia
- Undergoing bilateral knee surgery
- Subject who is considered by Investigator to be an unsuitable candidate
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Rush University
Chicago, Illinois, 60612
Ohio State University Sports Medicine
Columbus, Ohio, 43221
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, 80230
Duke University
Durham, North Carolina, 27710
Colorado Orthopedic Consultants, PC
Englewood, Colorado, 80110
Kerlan-Jobe Orthopaedic Clinic
Los Angeles, California, 90045
Temple University Orthopedics
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15203
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
Redwood City, California, 94063
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Double-Blind, Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects
OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.
Read the detailed description
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.
- Being tested
- OMS103HP, Vehicle
- Keywords
- Knee, Musculoskeletal System, Ligament, ACL reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS103HPDrug
Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
VehicleDrug
Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OMS103 Irrigation Solution Receives: Drug: OMS103HP |
| 2 | Placebo comparator | Balanced Salt Solution (BSS) Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall incidence of adverse events regardless of relationship to study drug.
Measured: 90 days
Secondary outcomes (1)
Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startOct 2004
- Primary completionMar 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Houston, Study director, Omeros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245271
- Sponsor's protocol ID
- C04516
- Status last verified
- Jun 2011
- First submitted
- 26 Oct 2005
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects
- ClinicalTrials.gov ID
- NCT00245271
- Acronym / sponsor ID
- C04516
- Keywords
- Knee, Musculoskeletal System, Ligament, ACL reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Oct 2005 (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.
OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.
Detailed description
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.
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 |
|---|---|---|
| 1 | Experimental | Drug: OMS103HPOMS103 Irrigation Solution |
| 2 | Placebo comparator | Drug: VehicleBalanced Salt Solution (BSS) |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 17 - 65 years of age
- In good general health
- Undergoing arthroscopic ACL reconstruction for an ACL tear
Key exclusion criteria (4 listed)
- Allergies to any of the individual ingredients in OMS103HP
- Has open physes in the distal femur or proximal tibia
- Undergoing bilateral knee surgery
- Subject who is considered by Investigator to be an unsuitable candidate
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 |
|---|---|---|
| OMS103HPMaximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours | Drug | 1 |
| VehicleMaximum of 13 bags of BSS irrigation over a maximum of 2 hours. | Drug | 2 |
Primary outcome
The overall incidence of adverse events regardless of relationship to study drug.
Time frame: 90 days
1 secondary outcome
Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).
Time frame: 30 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 27 Jun 2011.
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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.
Scott Houston study director
Omeros Corporation
10 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 in people with Anterior Cruciate Ligament Reconstruction, run by Omeros Corporation at 10 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 3 inclusion and 4 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The overall incidence of adverse events regardless of relationship to study drug. (time frame: 90 days). 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 27 Jun 2011.