Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty
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
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.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Postoperative Pain
Intervention
Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
Location
Investigator Site
Birmingham
Alabama
United States
35209
Status
Recruiting
Source
QRxPharma Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01055015
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lethal Dose 50
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Maximum Tolerated Dose
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Dose Fractionation
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
Radiotherapy, Conformal
Radiotherapy where there is improved dose homogeneity within the tumor and reduced dosage to uninvolved structures. The precise shaping of dose distribution is achieved via the use of computer-controlled multileaf collimators.
Dose-response Relationship, Immunologic
A specific immune response elicited by a specific dose of an immunologically active substance or cell in an organism, tissue, or cell.
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