Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty

NCT00818493 | Completed Phase 2

• 1 other identifier: Q8003-020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.

Conditions

Postoperative Pain

Keywords

total knee arthroplasty; total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Difference in pain intensity scores from baseline

  48 hours

Secondary Outcomes (1)

• Safety: adverse events

  Throughout the 48 hour period

Study Arms (3)

1

EXPERIMENTAL

Q8003, flexible ascending dose

Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)

2

EXPERIMENTAL

Low dose Q8003

Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)

3

ACTIVE COMPARATOR

Percocet (oxycodone and acetaminophen)

Drug: Percocet (oxycodone and acetaminophen)

Interventions

Q8003 (morphine sulfate and oxycodone hydrochloride) DRUG

IR Capsules, ascending flexible dose, every 4 to 6 hours

1

Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) DRUG

One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours

2

Percocet (oxycodone and acetaminophen) DRUG

One or two 5mg/325 mg tablets every 4 to 6 hours

3

Eligibility Criteria

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

You may qualify if:

• Male of female, at least 18 years of age at time of enrollment.
• If female, be at least one year post-menopausal, surgically sterile or practicing effective contraception, be non-lactating, and if of child-bearing potential, have a negative urine pregnancy test result.
• Have a body mass index (BMI) of 38 kg/m2 or less.
• Have undergone a primary unilateral total knee arthroplasty or total hip arthroplasty performed under standardized general, spinal or epidural anesthesia.
• Have developed 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 within 6 hours of discontinuing PCA on the morning after surgery).

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 \> 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).
• History of abusing licit or illicit drug substances within five (5) years of study entry.
• Has taken drugs known to interact with morphine or oxycodone metabolism, including, but not limited to, phenothiazines, monoamine oxidase inhibitors (MAOI), amphetamines, and muscle relaxants within the 4 weeks prior to the date of surgery.

Sponsors & Collaborators

• QRxPharma Inc.: lead

Study Sites (4)

West Alabama Research, Inc.

Birmingham, Alabama, 35209, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Research Concepts, Ltd.

Houston, Texas, 77024, United States

Location

Related Publications (1)

• Richards P, Gimbel JS, Minkowitz HS, Kelen R, Stern W. Comparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty. Clin Ther. 2013 Apr;35(4):498-511. doi: 10.1016/j.clinthera.2013.03.002. Epub 2013 Mar 29.

  PMID: 23545428 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MoxDuo; Morphine; Oxycodone; oxycodone-acetaminophen; Acetaminophen

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; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Patricia T. Richards, MD, Ph.D.

  QRxPharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (4)