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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016808
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
QRxPharma Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Postoperative Pain Drug: Q8003 Drug: Morphine sulfate Drug: Oxycodone HCl Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Q8003 12 mg/8 mg
Drug: Q8003
Q8003 is a combination of morphine sulfate and oxycodone HCl
Active Comparator: Morphine sulfate 12 mg
Single component
Drug: Morphine sulfate
One morphine sulfate 12 mg IR capsule q6h
Active Comparator: Oxycodone HCl 8 mg
Single component
Drug: Oxycodone HCl
One oxycodone HCl 8 mg IR Capsule q6h

Primary Outcome Measures :
  1. Difference in pain intensity scores from baseline [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Safety: adverse events, moderate and severe reports of opioid-related adverse events [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016808

United States, California
Investigator Site
Anaheim, California, United States, 92801
United States, Maryland
Investigator Site
Owings Mills, Maryland, United States, 21117
Investigator Site
Pasadena, Maryland, United States, 21122
United States, Texas
Investigator Site
San Antonio, Texas, United States, 78229
United States, Utah
Investigator Site
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
QRxPharma Inc.
Study Director: Patricia T. Richards, MD, Ph.D. QRxPharma Inc.

Responsible Party: QRxPharma Inc. Identifier: NCT01016808     History of Changes
Other Study ID Numbers: Q8003-008
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Keywords provided by QRxPharma Inc.:

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents