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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QRxPharma Inc.
ClinicalTrials.gov Identifier:
NCT01055015
First received: January 22, 2010
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Postoperative Pain
Drug: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)
Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Study of the Analgesic Efficacy and Safety of Flexible Dose Q8003 Versus Low Dose Q8003 in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by QRxPharma Inc.:

Primary Outcome Measures:
  • Difference in pain intensity scores from baseline [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: adverse events, opioid-related signs and symptoms [ Time Frame: Throughout the 48-hour period and during the voluntary safety extension period. ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Q8003, Flexible dose
Drug: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)
IR Capsules, flexible dose, every 4 to 6 hours
Experimental: 2
Q8003, Low dose
Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
One 3 mg/2 mg IR Capsule every 4 to 6 hours following a 6 mg/4 mg loading dose.

Detailed Description:

This Phase 3 study is a two-arm, double-blind study to:

  • compare the analgesic efficacy and safety of the flexible regimen of Q8003 (6 mg/4 mg up to 24 mg/16 mg) administered every 4-6 hours over a 48-hour Treatment Period versus low dose Q8003 (every 4-6 hours 3 mg/2 mg with a 6 mg/4 mg loading dose) to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty.
  • to evaluate the efficacy and safety of Q8003 when administered in the Voluntary Extension Period starting at 48 hours after the initial dosing and extending up to Day 12.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055015

Locations
United States, Alabama
Investigator Site
Birmingham, Alabama, United States, 35209
Investigator Site
Sheffield, Alabama, United States, 35660
United States, Arizona
Investigator Site
Phoenix, Arizona, United States, 85023
United States, California
Investigator Site
Laguna Hills, California, United States, 92653
Investigator Site
Long Beach, California, United States, 90806
Investigator Site
Pasadena, California, United States, 91105
United States, Colorado
Investigator Site
Englewood, Colorado, United States, 80110
United States, Florida
Investigator Site
Edgewater, Florida, United States, 32132
Investigator Site
Miami, Florida, United States, 33136
Investigator Site
Sarasota, Florida, United States, 34232
United States, Texas
Investigator Site
Houston, Texas, United States, 77024
Sponsors and Collaborators
QRxPharma Inc.
  More Information

No publications provided

Responsible Party: QRxPharma Inc.
ClinicalTrials.gov Identifier: NCT01055015     History of Changes
Other Study ID Numbers: Q8003-009
Study First Received: January 22, 2010
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by QRxPharma Inc.:
total knee arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Oxycodone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 29, 2014