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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831051
• Other study ID #: Q8003-021
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2009
• Last updated: May 15, 2012
• Start date: December 2008
• Est. completion date: February 2009

Study information

• Verified date: May 2012
• Source: QRxPharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Q8003
One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
• Morphine sulfate
One morphine sulfate 12mg IR capsule q6h
• Oxycodone HCl
One oxycodone HCl 8mg IR Capsule q6h
• Q8003
One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
• Morphine sulfate
Two morphine sulfate 3mg IR capsules q6h
• Oxycodone HCl 4mg
Two oxycodone HCl 2mg IR Capsules q6h

Locations

Country	Name	City	State
United States	Advanced Regional Center for Ankle and Foot Care	Altoona	Pennsylvania
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Crossroads Research, Inc.	Owings Mills	Maryland
United States	Chesapeake Foot and Ankle	Pasadena	Maryland
United States	Associated Foot and Ankle Specialists	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
QRxPharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain intensity scores from baseline		48 hours	No
Secondary	Safety: adverse events		48 hours	Yes