Clinical trial NCT01016808: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Postoperative Pain
Keywords: Bunionectomy
Opioids
Lead sponsor: QRxPharma Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Difference in pain intensity scores from baseline
timeFrame: 48 hours
Secondary outcomes:
measure: Safety: adverse events, moderate and severe reports of opioid-related adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Investigator Site
state: California
city: Owings Mills
country: United States
facility: Investigator Site
state: Maryland
city: Pasadena
country: United States
facility: Investigator Site
state: Maryland
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigator Site
state: Utah
Study officials:
affiliation: QRxPharma Inc.
name: Patricia T. Richards, MD, Ph.D.
role: STUDY_DIRECTOR
References: