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

NCT01016808 | Completed Phase 3

• 1 other identifier: Q8003-008
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 5

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.

Conditions

Moderate to Severe Postoperative Pain

Keywords

Bunionectomy; Opioids

Outcome Measures

Primary Outcomes (1)

• Difference in pain intensity scores from baseline

  48 hours

Secondary Outcomes (1)

• Safety: adverse events, moderate and severe reports of opioid-related adverse events

  48 hours

Study Arms (3)

Q8003 12 mg/8 mg

EXPERIMENTAL

Combination

Drug: Q8003

Morphine sulfate 12 mg

ACTIVE COMPARATOR

Single component

Drug: Morphine sulfate

Oxycodone HCl 8 mg

ACTIVE COMPARATOR

Single component

Drug: Oxycodone HCl

Interventions

Q8003 DRUG

Q8003 is a combination of morphine sulfate and oxycodone HCl

Q8003 12 mg/8 mg

Morphine sulfate DRUG

One morphine sulfate 12 mg IR capsule q6h

Morphine sulfate 12 mg

Oxycodone HCl DRUG

One oxycodone HCl 8 mg IR Capsule q6h

Oxycodone HCl 8 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• QRxPharma Inc.: lead

Study Sites (5)

Investigator Site

Anaheim, California, 92801, United States

Location

Investigator Site

Owings Mills, Maryland, 21117, United States

Location

Investigator Site

Pasadena, Maryland, 21122, United States

Location

Investigator Site

San Antonio, Texas, 78229, United States

Location

Investigator Site

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

MoxDuo; Morphine; Oxycodone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• Patricia T. Richards, MD, Ph.D.

  QRxPharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (5)