Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

Study Overview
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Brief Summary
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This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Official Title
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A Double-Blind, Randomized, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of the Opioid Combination Q8003 to Each of the Individual Milligram Components (Oxycodone and Morphine) in the Management of Acute Moderate to Severe Pain Following Bunionectomy Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Q8003
* Drug: Morphine sulfate
* Drug: Oxycodone HCl
* Drug: Q8003
* Drug: Morphine sulfate
* Drug: Oxycodone HCl 4mg


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 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 > 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q8003 12mg/8mg<br>Combination | Drug: Q8003<br>* One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h<br>|
| Active Comparator: Morphine sulfate 12 mg<br>Single component | Drug: Morphine sulfate<br>* One morphine sulfate 12mg IR capsule q6h<br>|
| Active Comparator: Oxycodone HCl 8mg<br>Single component | Drug: Oxycodone HCl<br>* One oxycodone HCl 8mg IR Capsule q6h<br>|
| Experimental: Q8003 6mg/4mg<br>Combination | Drug: Q8003<br>* One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h<br>|
| Active Comparator: Morphine sulfate 6mg<br>Single component | Drug: Morphine sulfate<br>* Two morphine sulfate 3mg IR capsules q6h<br>|
| Active Comparator: Oxycodone HCl 4mg<br>Single component | Drug: Oxycodone HCl 4mg<br>* Two oxycodone HCl 2mg IR Capsules q6h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain intensity scores from baseline |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events |  | 48 hours | 

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