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Sponsored by: |
QRxPharma Inc. |
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Information provided by: | QRxPharma Inc. |
ClinicalTrials.gov Identifier: | NCT00818493 |
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 |
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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 |
Estimated Enrollment: | 45 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Q8003, flexible ascending dose
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Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
IR Capsules, ascending flexible dose, every 4 to 6 hours
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2: Experimental
Low dose Q8003
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Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours
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3: Active Comparator
Percocet (oxycodone and acetaminophen)
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Drug: Percocet (oxycodone and acetaminophen)
One or two 5mg/325 mg tablets every 4 to 6 hours
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This Phase 2 study is a 3 arm, open-label pilot study to evaluate:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
West Alabama Research, Inc. | Recruiting |
Birmingham, Alabama, United States, 35209 | |
Contact: Call for information 287-727-6608 | |
United States, Arizona | |
Arizona Research Center | Recruiting |
Phoenix, Arizona, United States, 85023 | |
Contact: Call for information 602-863-6363 | |
United States, Michigan | |
William Beaumont Hospital | Recruiting |
Royal Oak, Michigan, United States, 48073 | |
Contact: Call for Information 248-964-2440 | |
United States, Texas | |
Research Concepts, Ltd. | Recruiting |
Houston, Texas, United States, 77024 | |
Contact: Call for Information 832-567-2273 |
Study Director: | Patricia T. Richards, MD, Ph.D. | QRxPharma Inc. |
Responsible Party: | QRxPharma, Inc. ( Patricia Richards, MD, Ph.D., Study Director ) |
Study ID Numbers: | Q8003-020 |
Study First Received: | January 6, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00818493 History of Changes |
Health Authority: | United States: Food and Drug Administration |
total knee arthroplasty total hip arthroplasty |
Morphine Oxycodone Central Nervous System Depressants Pain Narcotics Signs and Symptoms Postoperative Complications |
Analgesics, Non-Narcotic Analgesics Peripheral Nervous System Agents Pain, Postoperative Acetaminophen Analgesics, Opioid |
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 |