Official Title: “A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of Q8003 With Oxycodone and Morphine for the Management of Acute Moderate to Severe Postoperative Pain Following Bunionectomy Surgery”

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Drug: Q8003
  • Q8003 is a combination of morphine sulfate and oxycodone HCl
• Drug: Morphine sulfate
  • One morphine sulfate 12 mg IR capsule q6h
• Drug: Oxycodone HCl
  • One oxycodone HCl 8 mg IR Capsule q6h

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Q8003 12 mg/8 mg
  • Combination
• Active Comparator: Morphine sulfate 12 mg
  • Single component
• Active Comparator: Oxycodone HCl 8 mg
  • Single component

Primary Measures

• Difference in pain intensity scores from baseline
  • Time Frame: 48 hours
    Safety Issue?: No

Secondary Measures

• Safety: adverse events, moderate and severe reports of opioid-related adverse events
  • Time Frame: 48 hours
    Safety Issue?: Yes

Inclusion Criteria:

• Patient is male or female and at least 18 years of age.
• 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). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
• Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
• To be randomized after surgery, the patient must report 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).

Exclusion Criteria:

• 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
• > 4 weeks 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: QRxPharma Inc.

Overall Clinical Trial Officials and Contacts

Patricia T. Richards, MD, Ph.D. Study Director QRxPharma Inc.  

Overall Contact: QRxPharma Clinical Department  Recruitment1@qrxpharma.com

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016808

Study ID Number: Q8003-008

ClinicalTrials.gov Identifier: NCT01016808

Health Authority: United States: Food and Drug Administration