Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QRxPharma Inc.
ClinicalTrials.gov Identifier:
NCT01280331
First received: January 18, 2011
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
Drug: Morphine sulfate
Drug: Oxycodone HCl
Phase 3

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

Resource links provided by NLM:


Further study details as provided by QRxPharma Inc.:

Primary Outcome Measures:
  • Differences in desaturation events per standardized time unit [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in efficacy between Q8003 and its components (morphine and oxycodone) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Changes from baseline in pain intensity

  • Differences in the absence of emesis without the use of an anti-emetic (emesis complete response) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 375
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Q8003 12 mg/8 mg
Combination
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

  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 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).
  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: NCT01280331

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

No publications provided

Responsible Party: QRxPharma Inc.
ClinicalTrials.gov Identifier: NCT01280331     History of Changes
Other Study ID Numbers: Q8003-022
Study First Received: January 18, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by QRxPharma Inc.:
Bunionectomy

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

ClinicalTrials.gov processed this record on July 26, 2014