Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients

Study Overview
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Brief Summary
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This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.

Official Title
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A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Effects of Q8003 to the Morphine-Equivalent Doses of Oxycodone and of Morphine on the Opioid-Related Adverse Events of Moderate to Severe Nausea, Emesis, and Dizziness in Subjects With Acute Moderate-to-Severe Postoperative Pain Following Bunionectomy Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
* Drug: Morphine sulfate
* Drug: Oxycodone HCl


Participation Criteria
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Eligibility Criteria
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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 4 or more on the 11 point NPRS scale). At least 40% of study subjects will be 60 years of age or older. 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 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 acetaminophen. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q8003 12 mg/8 mg<br>Combination | Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)<br>* Two Q8003 6 mg/4 mg IR Capsules q6h<br>|
| Active Comparator: Morphine sulfate 24 mg<br>Single component | Drug: Morphine sulfate<br>* Two morphine sulfate 12 mg IR capsules q6h<br>|
| Active Comparator: Oxycodone HCl 16 mg<br>Single component | Drug: Oxycodone HCl<br>* Two oxycodone HCl 8 mg IR Capsules q6h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in desaturation events per standardized time unit |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in efficacy between Q8003 and its components (morphine and oxycodone) | Changes from baseline in pain intensity | 48 hours | 
| Differences in the absence of emesis without the use of an anti-emetic (emesis complete response) |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bunionectomy