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

Sponsor:	QRxPharma Inc.
Information provided by:	QRxPharma Inc.
ClinicalTrials.gov Identifier:	NCT00818493

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain	Drug: Q8003 (morphine sulfate and oxycodone hydrochloride) Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) Drug: Percocet (oxycodone and acetaminophen)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Pilot Study of the Analgesic Efficacy and Safety Of Q8003 and of the Conversion From IV Morphine PCA Analgesia to Q8003 or to Percocet® in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty or Total Hip Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Oxycodone Acetaminophen CT 2584 Vicodin Oxycodone hydrochloride

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	February 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Q8003, flexible ascending dose	Drug: Q8003 (morphine sulfate and oxycodone hydrochloride) IR Capsules, ascending flexible dose, every 4 to 6 hours
2: Experimental Low dose Q8003	Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours
3: Active Comparator Percocet (oxycodone and acetaminophen)	Drug: Percocet (oxycodone and acetaminophen) One or two 5mg/325 mg tablets every 4 to 6 hours

Detailed Description:

This Phase 2 study is a 3 arm, open-label pilot study to evaluate:

the analgesic efficacy of a flexible ascending regimen of Q8003 compared to a low dose regimen of Q8003 (3 mg/2 mg and potentially up to 6 mg/ 4mg) and to 1-2 Percocet® 5 mg/325 mg tablets. Study drug will be administered every 4-6 hours over a 48-hour Treatment Period to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
for the flexible ascending regimen of Q8003 treatment group, to evaluate the adequacy of the algorithm for conversion of IV PCA morphine to oral morphine equivalent doses of Q8003.
the safety of the flexible ascending regimen of Q8003 administered over a 48-hour Treatment Period.

Eligibility

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

Criteria

Inclusion Criteria:

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).

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818493

Locations

United States, Alabama
West Alabama Research, Inc.
Birmingham, Alabama, United States, 35209
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Texas
Research Concepts, Ltd.
Houston, Texas, United States, 77024

Sponsors and Collaborators

QRxPharma Inc.

Investigators

Study Director:

Patricia T. Richards, MD, Ph.D.

QRxPharma Inc.

More Information

No publications provided

Responsible Party:	QRxPharma, Inc. ( Patricia Richards, MD, Ph.D., Study Director )
Study ID Numbers:	Q8003-020
Study First Received:	January 6, 2009
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00818493 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by QRxPharma Inc.:

total knee arthroplasty
total hip arthroplasty

Additional relevant MeSH terms:

Morphine
Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Pain, Postoperative
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010