Efficacy and Safety of Q8003 in the Management of Post-bunionectomy Pain

NCT00560183 | Completed Phase 3

• 1 other identifier: Q8003-007
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 6

Brief Summary

This study will explore the efficacy and safety of a fixed dose combination of morphine and oxycodone for management of acute postoperative pain. The study will explore the efficacy dose response and dosing interval required to maintain adequate analgesia at each tested dosage strength.

Conditions

Postoperative Pain

Keywords

Acute; Bunionectomy

Outcome Measures

Primary Outcomes (1)

• Difference in pain intensity scores from baseline

  48 hours

Secondary Outcomes (2)

• Appropriate dosing interval for each tested dose level

  48 hours

• Safety: incidence of opioid-related adverse events

  48 hours

Study Arms (2)

1

EXPERIMENTAL

Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Q8003 (morphine sulfate and oxycodone hydrochloride) DRUG

Capsules, four different mg dosage strengths

1

Placebo DRUG

Capsules

2

Eligibility Criteria

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

You may qualify if:

• Patient is scheduled for bunionectomy surgery and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
• 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).
• Patient has normal laboratory values or abnormal values judged not clinically significant by the Investigator for clinical chemistry and hematology (\< 1.5 ULN).
• Patient is in general good health based on physical examination, medical history and clinically acceptable results for the following assessments: vital signs and a 12-lead electrocardiogram (ECG).
• Patient gives written informed consent and is able to understand the requirements of the study, adhere to the study restrictions, and be available for the required follow-up assessment.

You may not qualify if:

• Patient has a current acute or chronic disease that would interfere with evaluations of postoperative Q8003 efficacy or safety.
• Patient has a history of poor tolerance to short term opiate use in prior surgeries, based on patient self-report.
• Patient used opiates continuously (including tramadol) for more than five days in the past year.
• Patient has a history of pulmonary, cardiovascular, 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.
• Patient has positive HIV serology or signs of HIV infection or AIDS.
• Patient has positive HBsAg or HCV antibody.
• Patient is currently receiving any medications that are not at a stable dose (the same dose for \>2 month prior to date of surgery).
• Patient is currently receiving muscle relaxants, antipsychotic drugs, monoamine oxidase inhibitors, or any medications for the treatment of depression.
• Patient has used systemic corticosteroids within previous fourteen (14) days.
• Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
• Patient has 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).
• Patient has a history of abusing licit or illicit drug substances within five (5) years of study entry.
• Patient is obese with a body mass index \>32.

Sponsors & Collaborators

• QRxPharma Inc.: lead

Study Sites (6)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Advanced Regional Center for Foot and Ankle Care

Altoona, Pennsylvania, 16602, United States

Location

Scirex Research Center

Houston, Texas, 77081, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, 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

• Warren Stern, 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: November 14, 2007
• First Posted: November 19, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (6)