This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients
who have undergone primary unilateral total knee arthroplasty
Drug: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)
Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01055015
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
At least 18 years of age at time of enrollment.
If female, be at least one year post-menopausal, surgically sterile or practicing effective contraceptive, be non-lactating, and if of child-bearing potential, have a negative urine pregnancy test result.
Have a body mass index (BMI) of 38 kg/m2 or less.
Have undergone a primary unilateral total knee arthroplasty performed under under standardized general, spinal or epidural anesthesia.
Have developed moderate to severe pain (a score of 2 or more on the 4 point Likert scale and at least 4 on the 11 point NPRS scale within 6 hours of discontinuing PCA on the morning after surgery).
In the opinion of the Investigator, has a history of pulmonary, cardiovascular
(including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
Used opiates continuously (including tramadol) for more than ten days in the past year.
Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery).
Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
History of abusing licit or illicit drug substances within five (5) years of study entry.
Has taken drugs known to interact with morphine or oxycodone metabolism, including, but not limited to, phenothiazines, monoamine oxidase inhibitors (MAOI), amphetamines, and muscle relaxants within the 4 weeks prior to the date of surgery.
History of sleep apnea.
All locations for NCT01055015
United States (11)
Birmingham, Alabama, United States, 35209
Sheffield, Alabama, United States, 35660
Phoenix, Arizona, United States, 85023
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90806
Pasadena, California, United States, 91105
Englewood, Colorado, United States, 80110
Edgewater, Florida, United States, 32132
Miami, Florida, United States, 33136
Sarasota, Florida, United States, 34232
Houston, Texas, United States, 77024
View full eligibility
Tris trial is registered with FDA with number: NCT01055015. The sponsor of the trial is QRxPharma Inc. and it is looking for 141 volunteers for the current phase.
Official trial title: A Randomized, Double-Blind, Study of the Analgesic Efficacy and Safety of Flexible Dose Q8003 Versus Low Dose Q8003 in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty
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