Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients

NCT01280331 | Completed Phase 3

• 1 other identifier: Q8003-022
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.

Conditions

Postoperative Pain

Keywords

Bunionectomy

Outcome Measures

Primary Outcomes (1)

• Differences in desaturation events per standardized time unit

  48 hours

Secondary Outcomes (2)

• Difference in efficacy between Q8003 and its components (morphine and oxycodone)

  48 hours

• Differences in the absence of emesis without the use of an anti-emetic (emesis complete response)

  48 hours

Study Arms (3)

Q8003 12 mg/8 mg

EXPERIMENTAL

Combination

Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)

Morphine sulfate 24 mg

ACTIVE COMPARATOR

Single component

Drug: Morphine sulfate

Oxycodone HCl 16 mg

ACTIVE COMPARATOR

Single component

Drug: Oxycodone HCl

Interventions

Q8003 (morphine sulfate and oxycodone hydrochloride) DRUG

Two Q8003 6 mg/4 mg IR Capsules q6h

Q8003 12 mg/8 mg

Morphine sulfate DRUG

Two morphine sulfate 12 mg IR capsules q6h

Morphine sulfate 24 mg

Oxycodone HCl DRUG

Two oxycodone HCl 8 mg IR Capsules q6h

Oxycodone HCl 16 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 4 or more on the 11 point NPRS scale).
• At least 40% of study subjects will be 60 years of age or older.

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 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 acetaminophen.
• 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).

Sponsors & Collaborators

• QRxPharma Inc.: lead

Study Sites (4)

Investigational site

Anaheim, California, 92801, United States

Location

Investigational site

Owings Mills, Maryland, 21117, United States

Location

Investigational site

Pasadena, Maryland, 21122, United States

Location

Investigational Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MoxDuo; Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 20, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (4)