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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Q8003; Drug: Q8003; Drug: Morphine sulfate; Drug: Morphine sulfate; Drug: Oxycodone HCl; Drug: Oxycodone HCl 4mg

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Associated Foot and Ankle Specialists
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Crossroads Research, Inc.
    • Pasadena, Maryland, United States, 21122
      • Chesapeake Foot and Ankle
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 92801
      • Advanced Regional Center for Ankle and Foot Care
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: adverse events	48 hours

Collaborators and Investigators

• Sponsor: QRxPharma Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: January 27, 2009
• First Submitted That Met QC Criteria: January 27, 2009
• First Posted (Estimate): January 28, 2009

Study Record Updates

• Last Update Posted (Estimate): May 17, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Bunionectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Oxycodone
• Other Study ID Numbers: Q8003-021