Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty

NCT01055015 | Completed Phase 3

• 1 other identifier: Q8003-009
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 11

Brief Summary

This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty

Conditions

Postoperative Pain

Keywords

total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Difference in pain intensity scores from baseline

  48 hours

Secondary Outcomes (1)

• Safety: adverse events, opioid-related signs and symptoms

  Throughout the 48-hour period and during the voluntary safety extension period.

Study Arms (2)

1

EXPERIMENTAL

Q8003, Flexible dose

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

2

EXPERIMENTAL

Q8003, Low dose

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

Interventions

Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) DRUG

IR Capsules, flexible dose, every 4 to 6 hours

1

Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) DRUG

One 3 mg/2 mg IR Capsule every 4 to 6 hours following a 6 mg/4 mg loading dose.

2

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at time of enrollment.
• If female, be at least one year post-menopausal, surgically sterile or practicing effective contraceptive, 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 performed under 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 and 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.
• History of sleep apnea.

Sponsors & Collaborators

• QRxPharma Inc.: lead

Study Sites (11)

Investigator Site

Birmingham, Alabama, 35209, United States

Location

Investigator Site

Sheffield, Alabama, 35660, United States

Location

Investigator Site

Phoenix, Arizona, 85023, United States

Location

Investigator Site

Laguna Hills, California, 92653, United States

Location

Investigator Site

Long Beach, California, 90806, United States

Location

Investigator Site

Pasadena, California, 91105, United States

Location

Investigator Site

Englewood, Colorado, 80110, United States

Location

Investigator Site

Edgewater, Florida, 32132, United States

Location

Investigator Site

Miami, Florida, 33136, United States

Location

Investigator Site

Sarasota, Florida, 34232, United States

Location

Investigator Site

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Oxycodone; MoxDuo

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 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 22, 2010
• First Posted: January 25, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (11)