Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

Phase 3

Completed

• Conditions: Moderate to Severe Postoperative Pain
• Interventions: Drug: Oxycodone HCl; Drug: Q8003; Drug: Morphine sulfate

• Registration Number: NCT01016808
• Lead Sponsor: QRxPharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2009-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2010-12-06
• Disposition First Submitted QC: 2010-12-06
• Disposition First Posted: 2010-12-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 522

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone HCl 8 mg	Oxycodone HCl	Single component
Q8003 12 mg/8 mg	Q8003	Combination
Morphine sulfate 12 mg	Morphine sulfate	Single component

Primary Outcome Measures

Name	Time	Method
Difference in pain intensity scores from baseline	48 hours

Secondary Outcome Measures

Name	Time	Method
Safety: adverse events, moderate and severe reports of opioid-related adverse events	48 hours

Trial Locations

Locations (1)

Investigator Site; 🇺🇸 Salt Lake City, Utah, United States