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news.QRxPharma, a specialty pharmaceutical company, has initiated a comparative three-arm pilot study to evaluate the analgesic efficacy and safety profile of MoxDuo IR capsules in patients who have undergone total knee replacement surgery.
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Data from this study will be used to further establish the optimal dose regimen for MoxDuo IR, select an appropriate control group, and properly design an upcoming pivotal Phase III trial in patients following total knee replacement surgery.
In this clinical trial, each group of patients experiencing moderate to severe postoperative pain following total knee replacement will be treated every four to six hours over a 48-hour period. The study is targeted to enroll a total of 45 patients at three US clinical research sites.
Primary objectives of the study include: comparing the analgesic efficacy and safety profile of MoxDuo IR against control groups of patients receiving Percocet, a frequently used opioid for the treatment of pain, and comparing MoxDuo IR against the present standard use of intravenous morphine in patients who self-control their pain relief using ‘patient controlled analgesia’.
The company expects to complete dosing in April 2009 and is on track to launch MoxDuo IR in the US marketplace in 2011.
John Holaday, managing director and CEO of QRxPharma, said: This study represents an important step forward as the data collected will not only provide critical insights for structuring Phase III trials leading to product approval, but also serve as an important indicator of the clinical and commercial value MoxDuo IR offers.