Status:
COMPLETED
Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty
Lead Sponsor:
QRxPharma Inc.
Conditions:
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
Detailed Description
This Phase 2 study is a 3 arm, open-label pilot study to evaluate: * the analgesic efficacy of a flexible ascending regimen of Q8003 compared to a low dose regimen of Q8003 (3 mg/2 mg and potentially...
Eligibility Criteria
Inclusion
- Male of female, at least 18 years of age at time of enrollment.
- If female, be at least one year post-menopausal, surgically sterile or practicing effective contraception, 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 or total hip arthroplasty performed 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 or at least 4 on the 11 point NPRS scale within 6 hours of discontinuing PCA on the morning after surgery).
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00818493
Start Date
February 1 2009
End Date
July 1 2009
Last Update
May 17 2012
Active Locations (4)
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1
West Alabama Research, Inc.
Birmingham, Alabama, United States, 35209
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
Research Concepts, Ltd.
Houston, Texas, United States, 77024