Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
Primary Purpose
Moderate to Severe Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Q8003
Morphine sulfate
Oxycodone HCl
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Postoperative Pain focused on measuring Bunionectomy, Opioids
Eligibility 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).
Sites / Locations
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Q8003 12 mg/8 mg
Morphine sulfate 12 mg
Oxycodone HCl 8 mg
Arm Description
Combination
Single component
Single component
Outcomes
Primary Outcome Measures
Difference in pain intensity scores from baseline
Secondary Outcome Measures
Safety: adverse events, moderate and severe reports of opioid-related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01016808
Brief Title
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QRxPharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Postoperative Pain
Keywords
Bunionectomy, Opioids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
522 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Q8003 12 mg/8 mg
Arm Type
Experimental
Arm Description
Combination
Arm Title
Morphine sulfate 12 mg
Arm Type
Active Comparator
Arm Description
Single component
Arm Title
Oxycodone HCl 8 mg
Arm Type
Active Comparator
Arm Description
Single component
Intervention Type
Drug
Intervention Name(s)
Q8003
Intervention Description
Q8003 is a combination of morphine sulfate and oxycodone HCl
Intervention Type
Drug
Intervention Name(s)
Morphine sulfate
Intervention Description
One morphine sulfate 12 mg IR capsule q6h
Intervention Type
Drug
Intervention Name(s)
Oxycodone HCl
Intervention Description
One oxycodone HCl 8 mg IR Capsule q6h
Primary Outcome Measure Information:
Title
Difference in pain intensity scores from baseline
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Safety: adverse events, moderate and severe reports of opioid-related adverse events
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia T. Richards, MD, Ph.D.
Organizational Affiliation
QRxPharma Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Investigator Site
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Investigator Site
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
We'll reach out to this number within 24 hrs