Postoperative PainPhase 2/3C07-004NCT00624845
Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy
A Phase 2/3 study testing OMS103HP in people with Postoperative Pain, run by Omeros Corporation at 8 sites in United States.
Trial summary
The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- OMS103HP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2007to May 2009
- Phase
- Phase 2/3
- 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
- Subject has voluntarily signed informed consent form, including HIPAA Authorization.
- Subject is ≥ 18 and ≤ 75 years of age.
- Subject is in good general health with a traumatic or degenerative meniscal cartilage injury (full tear) that occurred at least 14 days prior to the day of arthroscopic surgery.
- Subject is undergoing unilateral meniscectomy.
- Subject's physical examination is within normal limits or examination is clinically nonsignificant as determined by the Investigator, and subject is in good general health.
- Subject's laboratory evaluations are within normal limits or evaluations are clinically nonsignificant as determined by the Investigator.
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- Subject, if female and of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) agrees to use an effective method of birth control for the duration of her study involvement.
- Subject is at minimal risk from anesthesia and is 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). See Appendix VI.
- Subject agrees to refrain from taking the excluded medications listed in Exclusion Criteria through postoperative Day 7 (except for authorized analgesic medications) unless written permission has been granted by Omeros.
- Subject is able to be proficient in the use of the ePRO device (documented at the site).
Who cannot join
- Subject with significant arthritis (>2 on the Kellgren-Lawrence Scale).
- Subject with a history of reactive synovial disease.
- Subject with current, or history of, 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 any sensory deficit of the lower extremities.
- Subject with current, or history of fibromyalgia.
- Subject taking ANY ANALGESIC (including salicylates, opioids, propoxyphene, etc.) on the day of surgery from 12:00 A.M. until after the procedure, except for medications authorized by the Investigator or delegated staff.
- Subject taking any of the following medications within the stated time frames prior to the day of surgery.
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- Amitriptyline within 30 days
- More than two doses of sumatriptan, (or any other drug in the triptan class), ondansetron, or other prescription serotonergic or histaminic drug within 14 days
- More than two doses of any oral, parenteral, or intravenous steroids (e.g., dexamethasone for antiemetic prophylaxis) within 3 months
- More than two doses of oxymetazoline or other nasal decongestant/cold/cough/allergy medication (including loratadine) within 7 days
- More than two doses of ketoprofen or other NSAID (including COX-2 inhibitors) within 7 days (except for piroxicam, as indicated below)
- Subject who has taken more than two doses of opioid pain medication within the prior seven days of surgery or chronic use of opioid pain medications for greater than 6 weeks within the prior year
- More than two doses of piroxicam within 14 days
- Subject with a history of intra-articular corticosteroid injection in the operative knee within the two months prior to the meniscectomy
- Subject expected to undergo any of the following procedures concurrent with meniscectomy:
- Arthroscopic patellar tendon debridement
- Patellar alignment
- Lateral or retinacular release
- Excision synovectomy (minor synovectomy to improve arthroscopic visualization is acceptable)
- Concurrent ligamentous procedure
- Microfracture
- Abrasion arthroplasty
- Chondral transplantation
- Use of more than three portals
- Subject with allergies to any of the individual ingredients in OMS103HP, to related compounds (e.g., other NSAIDs or tricyclic antidepressants), or to opioid analgesics.
- Subject who is pregnant or breast-feeding.
- Subject with Worker's Compensation claim(s) under dispute or mediation.
- Subject with history of drug or alcohol abuse.
- Subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.
- Subject with a history or presence of systemic disease (renal, hepatic, psychiatric, etc.), which in the opinion of the Medical Monitor and the Principal Investigator, may place the subject's health at risk by participation in the study.
- Subject who is expected to receive a regional block for analgesia for this procedure.
- Subject who is considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Advanced Orthopedic and Sports Medicine Specialists
Aurora, Colorado, 80014
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, 21218
Colorado Orthopedic Consultants
Englewood, Colorado, 80110
Kerlan-Jobe Orthopaedic Clinic - Westchester
Los Angeles, California, 90045
Unlimited Research
San Antonio, Texas, 78217
University Orthopedics Center
State College, Pennsylvania, 16801
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Visions Clinical Research
Tucson, Arizona, 85712
About this study
Official title: Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP
The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.
- Conditions
- Postoperative Pain
- Being tested
- OMS103HP, Vehicle
- Keywords
- Meniscectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS103HPDrug
Maximum 6 bags of OMS103HP irrigation solution
VehicleDrug
Maximum of 6 bags of vehicle irrigation solution
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Not described Receives: Drug: OMS103HP |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the mean VAS at 24 hours postoperatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT00624845
- Sponsor's protocol ID
- C07-004
- Acronym
- C07-004
- Status last verified
- Jun 2011
- First submitted
- 19 Feb 2008
- 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 Comparing the Efficacy and Safety of OMS103HP
- ClinicalTrials.gov ID
- NCT00624845
- Acronym / sponsor ID
- C07-004 / C07-004
- Conditions
- Postoperative Pain
- Keywords
- Meniscectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Feb 2008 (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 benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.
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 |
|---|---|---|
| Drug | Experimental | Drug: OMS103HP |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has voluntarily signed informed consent form, including HIPAA Authorization.
- Subject is ≥ 18 and ≤ 75 years of age.
- Subject is in good general health with a traumatic or degenerative meniscal cartilage injury (full tear) that occurred at least 14 days prior to the day of arthroscopic surgery.
- Subject is undergoing unilateral meniscectomy.
- Subject's physical examination is within normal limits or examination is clinically nonsignificant as determined by the Investigator, and subject is in good general health.
Key exclusion criteria (32 listed)
- Subject with significant arthritis (>2 on the Kellgren-Lawrence Scale).
- Subject with a history of reactive synovial disease.
- Subject with current, or history of, 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 any sensory deficit of the lower extremities.
- Subject with current, or history of fibromyalgia.
- Subject taking ANY ANALGESIC (including salicylates, opioids, propoxyphene, etc.) on the day of surgery from 12:00 A.M. until after the procedure, except for medications authorized by the Investigator or delegated staff.
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 6 bags of OMS103HP irrigation solution | Drug | Drug |
| VehicleMaximum of 6 bags of vehicle irrigation solution | Drug | Vehicle |
Primary outcome
The primary efficacy endpoint is the mean VAS at 24 hours postoperatively.
Time frame: 24 hours
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OMS103HP in people with Postoperative Pain, run by Omeros Corporation at 8 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 10 inclusion and 32 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 8 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 primary efficacy endpoint is the mean VAS at 24 hours postoperatively. (time frame: 24 hours). 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.