phase III trial


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phase III trial

, phase 3 trial
A clinical trial to explore the clinical use of a new drug, esp. relative to other known effective agents (the current standard of care). These trials often include thousands of enrollee patients. By law, all such patients receive real treatment; no placebos are given. But the trial is usually double-blinded, with patients divided randomly into two groups: an experimental group and a control group on standard treatment, with neither patients nor researchers knowing to which group the patient belongs.
See also: trial
References in periodicals archive ?
The pivotal Phase III trial evaluated the efficacy and safety of a six day course of oral tedizolid phosphate therapy versus 10 days of oral therapy with linezolid (Zyvox) in 667 patients.
The pivotal Phase III trial, the final trial required before Litx can be submitted for marketing approval, is designed to demonstrate the Litx system's safety and efficacy.
When administered in combination with chemotherapy and after tumor resection, osteosarcoma patients in the phase III trial, patients receiving Junovan had a significant improvement in Disease Free Survival (DFS) (p<0.
The agreement which involves both process development and manufacturing of the biopharmaceutical drug substance for this clinical phase III trial, means that we will utilize our extensive expertise and broad experience in protein pharmaceuticals to the full extent," says Hans EurstrEm, SVP Biovitrum Biopharmaceuticals and Marketing & Sales.
The Children's Oncology Group performed the phase III trial in which 678 patients with newly diagnosed non-metastatic resectable high grade osteosarcoma were treated with Mepact in combination with chemotherapy following surgery.
Paul Meyers, Vice Chair of Pediatrics at Memorial Sloan-Kettering Cancer Center and principal investigator for the Phase III trial, said, "Osteosarcoma is a childhood cancer for which the outcome, despite advances in surgical and chemotherapeutic approaches, can be very poor in a substantial proportion of patients.
PROCHYMAL is being evaluated in a Phase III trial for the treatment of Graft vs.
We are making plans to initiate a Phase III trial in adults in the first half of calendar 2007, and to conduct a small pharmacokinetic study in children to enable us to choose doses for a Phase II / III pediatric study to start later in 2007.
Cobalis completed a Phase III trial in 2005 that demonstrated that patients who had taken PreHistin showed a reduction of allergy symptoms.
After having successfully completed Phase II clinical trials, Altus had previously planned to initiate Phase III trials for both programs in the second half of this year.