Efficacy and Safety of Q8003 in the Management of Post-bunionectomy Pain

This is an interventional treatment trial for Postoperative Pain focused on measuring Acute, Bunionectomy Read More

Inclusion Criteria:

• Patient is scheduled for bunionectomy surgery and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
• Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥12 months).
• Patient has normal laboratory values or abnormal values judged not clinically significant by the Investigator for clinical chemistry and hematology (< 1.5 ULN).
• Patient is in general good health based on physical examination, medical history and clinically acceptable results for the following assessments: vital signs and a 12-lead electrocardiogram (ECG).
• Patient gives written informed consent and is able to understand the requirements of the study, adhere to the study restrictions, and be available for the required follow-up assessment.

Exclusion Criteria:

• Patient has a current acute or chronic disease that would interfere with evaluations of postoperative Q8003 efficacy or safety.
• Patient has a history of poor tolerance to short term opiate use in prior surgeries, based on patient self-report.
• Patient used opiates continuously (including tramadol) for more than five days in the past year.
• Patient has a history of pulmonary, cardiovascular, 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.
• Patient has positive HIV serology or signs of HIV infection or AIDS.
• Patient has positive HBsAg or HCV antibody.
• Patient is currently receiving any medications that are not at a stable dose (the same dose for >2 month prior to date of surgery).
• Patient is currently receiving muscle relaxants, antipsychotic drugs, monoamine oxidase inhibitors, or any medications for the treatment of depression.
• Patient has used systemic corticosteroids within previous fourteen (14) days.
• Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
• Patient has 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).
• Patient has a history of abusing licit or illicit drug substances within five (5) years of study entry.
• Patient is obese with a body mass index >32.