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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QRxPharma Inc.
ClinicalTrials.gov Identifier:
NCT01016808
First received: November 19, 2009
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Moderate to Severe Postoperative Pain
Drug: Q8003
Drug: Morphine sulfate
Drug: Oxycodone HCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by QRxPharma Inc.:

Primary Outcome Measures:
  • Difference in pain intensity scores from baseline [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: adverse events, moderate and severe reports of opioid-related adverse events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 522
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Q8003 12 mg/8 mg
Combination
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016808

Locations
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.
Investigators
Study Director: Patricia T. Richards, MD, Ph.D. QRxPharma Inc.
  More Information

No publications provided

Responsible Party: QRxPharma Inc.
ClinicalTrials.gov Identifier: NCT01016808     History of Changes
Other Study ID Numbers: Q8003-008
Study First Received: November 19, 2009
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by QRxPharma Inc.:
Bunionectomy
Opioids

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014