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:
NCT00831051
First received: January 27, 2009
Last updated: May 15, 2012
Last verified: May 2012

January 27, 2009
May 15, 2012
December 2008
January 2009   (final data collection date for primary outcome measure)
Difference in pain intensity scores from baseline [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831051 on ClinicalTrials.gov Archive Site
Safety: adverse events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Safety: adverse events, opioid-related signs and symptoms [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
A Double-Blind, Randomized, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of the Opioid Combination Q8003 to Each of the Individual Milligram Components (Oxycodone and Morphine) in the Management of Acute Moderate to Severe Pain Following Bunionectomy Surgery

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: Q8003
    One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
  • Drug: Morphine sulfate
    One morphine sulfate 12mg IR capsule q6h
  • Drug: Oxycodone HCl
    One oxycodone HCl 8mg IR Capsule q6h
  • Drug: Q8003
    One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
  • Drug: Morphine sulfate
    Two morphine sulfate 3mg IR capsules q6h
  • Drug: Oxycodone HCl 4mg
    Two oxycodone HCl 2mg IR Capsules q6h
  • Experimental: Q8003 12mg/8mg
    Combination
    Intervention: Drug: Q8003
  • Active Comparator: Morphine sulfate 12 mg
    Single component
    Intervention: Drug: Morphine sulfate
  • Active Comparator: Oxycodone HCl 8mg
    Single component
    Intervention: Drug: Oxycodone HCl
  • Experimental: Q8003 6mg/4mg
    Combination
    Intervention: Drug: Q8003
  • Active Comparator: Morphine sulfate 6mg
    Single component
    Intervention: Drug: Morphine sulfate
  • Active Comparator: Oxycodone HCl 4mg
    Single component
    Intervention: Drug: Oxycodone HCl 4mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
February 2009
January 2009   (final data collection date for primary outcome measure)

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 > 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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831051
Q8003-021
No
QRxPharma Inc.
QRxPharma Inc.
Not Provided
Study Director: Patricia T. Richards, MD, Ph.D. QRxPharma Inc.
QRxPharma Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP