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Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) 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: NCT01280331
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
QRxPharma Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Q8003 (morphine sulfate and oxycodone hydrochloride) Drug: Morphine sulfate Drug: Oxycodone HCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Q8003 12 mg/8 mg
Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
Two Q8003 6 mg/4 mg IR Capsules q6h

Active Comparator: Morphine sulfate 24 mg
Single component
Drug: Morphine sulfate
Two morphine sulfate 12 mg IR capsules q6h

Active Comparator: Oxycodone HCl 16 mg
Single component
Drug: Oxycodone HCl
Two oxycodone HCl 8 mg IR Capsules q6h

Primary Outcome Measures :
  1. Differences in desaturation events per standardized time unit [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Difference in efficacy between Q8003 and its components (morphine and oxycodone) [ Time Frame: 48 hours ]
    Changes from baseline in pain intensity

  2. Differences in the absence of emesis without the use of an anti-emetic (emesis complete response) [ Time Frame: 48 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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).

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): NCT01280331

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United States, California
Investigational site
Anaheim, California, United States, 92801
United States, Maryland
Investigational site
Owings Mills, Maryland, United States, 21117
Investigational site
Pasadena, Maryland, United States, 21122
United States, Texas
Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
QRxPharma Inc.
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Study Director: Patricia T. Richards, MD, Ph.D. QRxPharma Inc.
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Responsible Party: QRxPharma Inc. Identifier: NCT01280331    
Other Study ID Numbers: Q8003-022
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012
Keywords provided by QRxPharma Inc.:
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents