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Efficacy and Safety of Q8003 in the Management of Post-bunionectomy Pain

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: NCT00560183
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
QRxPharma Inc.

Brief Summary:
This study will explore the efficacy and safety of a fixed dose combination of morphine and oxycodone for management of acute postoperative pain. The study will explore the efficacy dose response and dosing interval required to maintain adequate analgesia at each tested dosage strength.

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

Detailed Description:
This study is a randomized, double-blind, placebo-controlled, rising-dose/by-cohort study of the efficacy and safety of Q8003 in inpatients with acute pain following unilateral bunionectomy surgery. Patients in each dosing group will receive either Q8003 (approximately 50 per dosing group) or placebo (approximately 13 per dosing group), determined by random sequential assignment and blinded to patients and managing Investigators. Dosing groups will be enrolled sequentially in ascending order; only one dosing group will be open at a time for enrollment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Double-blind Study of the Safety and Efficacy of Q8003 in the Management of Post-bunionectomy Pain
Study Start Date : November 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1 Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
Capsules, four different mg dosage strengths

Placebo Comparator: 2 Drug: Placebo

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

Secondary Outcome Measures :
  1. Appropriate dosing interval for each tested dose level [ Time Frame: 48 hours ]
  2. Safety: incidence 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is scheduled for bunionectomy surgery and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
  • 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).
  • Patient has normal laboratory values or abnormal values judged not clinically significant by the Investigator for clinical chemistry and hematology (< 1.5 ULN).
  • Patient is in general good health based on physical examination, medical history and clinically acceptable results for the following assessments: vital signs and a 12-lead electrocardiogram (ECG).
  • Patient gives written informed consent and is able to understand the requirements of the study, adhere to the study restrictions, and be available for the required follow-up assessment.

Exclusion Criteria:

  • Patient has a current acute or chronic disease that would interfere with evaluations of postoperative Q8003 efficacy or safety.
  • Patient has a history of poor tolerance to short term opiate use in prior surgeries, based on patient self-report.
  • Patient used opiates continuously (including tramadol) for more than five days in the past year.
  • Patient has a history of pulmonary, cardiovascular, 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.
  • Patient has positive HIV serology or signs of HIV infection or AIDS.
  • Patient has positive HBsAg or HCV antibody.
  • Patient is currently receiving any medications that are not at a stable dose (the same dose for >2 month prior to date of surgery).
  • Patient is currently receiving muscle relaxants, antipsychotic drugs, monoamine oxidase inhibitors, or any medications for the treatment of depression.
  • Patient has used systemic corticosteroids within previous fourteen (14) days.
  • Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
  • Patient has 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).
  • Patient has a history of abusing licit or illicit drug substances within five (5) years of study entry.
  • Patient is obese with a body mass index >32.

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): NCT00560183

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United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Pennsylvania
Advanced Regional Center for Foot and Ankle Care
Altoona, Pennsylvania, United States, 16602
United States, Texas
Scirex Research Center
Houston, Texas, United States, 77081
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
QRxPharma Inc.
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Study Director: Warren Stern, Ph.D. QRxPharma Inc.

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Responsible Party: QRxPharma Inc. Identifier: NCT00560183    
Other Study ID Numbers: Q8003-007
First Posted: November 19, 2007    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
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents