Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
This study has been completed.
Sponsor:
QRxPharma Inc.
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
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: Q8003 Drug: Morphine sulfate Drug: Oxycodone HCl Drug: Oxycodone HCl 4mg |
Phase 2 |
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 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 |
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 [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Enrollment: | 197 |
Study Start Date: | December 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Q8003 12mg/8mg
Combination
|
Drug: Q8003
One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
|
Active Comparator: Morphine sulfate 12 mg
Single component
|
Drug: Morphine sulfate
One morphine sulfate 12mg IR capsule q6h
|
Active Comparator: Oxycodone HCl 8mg
Single component
|
Drug: Oxycodone HCl
One oxycodone HCl 8mg IR Capsule q6h
|
Experimental: Q8003 6mg/4mg
Combination
|
Drug: Q8003
One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
|
Active Comparator: Morphine sulfate 6mg
Single component
|
Drug: Morphine sulfate
Two morphine sulfate 3mg IR capsules q6h
|
Active Comparator: Oxycodone HCl 4mg
Single component
|
Drug: Oxycodone HCl 4mg
Two oxycodone HCl 2mg 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 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831051
Locations
United States, Arizona | |
Associated Foot and Ankle Specialists | |
Phoenix, Arizona, United States, 85050 | |
United States, California | |
Advanced Clinical Research Institute | |
Anaheim, California, United States, 92801 | |
United States, Maryland | |
Crossroads Research, Inc. | |
Owings Mills, Maryland, United States, 21117 | |
Chesapeake Foot and Ankle | |
Pasadena, Maryland, United States, 21122 | |
United States, Pennsylvania | |
Advanced Regional Center for Ankle and Foot Care | |
Altoona, Pennsylvania, United States, 92801 | |
United States, Utah | |
Jean Brown Research | |
Salt Lake City, Utah, United States, 84124 |
Sponsors and Collaborators
QRxPharma Inc.
Investigators
Study Director: | Patricia T. Richards, MD, Ph.D. | QRxPharma Inc. |
More Information
No publications provided
Keywords provided by QRxPharma Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
Responsible Party: | QRxPharma Inc. |
ClinicalTrials.gov Identifier: | NCT00831051 History of Changes |
Other Study ID Numbers: | Q8003-021 |
Study First Received: | January 27, 2009 |
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 October 18, 2012