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 ?
All 45 MPS I patients from the six-month, randomized, double-blind, placebo-controlled Phase 3 trial were enrolled in the open-label extension study in order to further evaluate the safety and efficacy of Aldurazyme.
We are hopeful that the combined use of both clinical and molecular indicators of efficacy in our phase 3 trial will enable us to confirm the utility of BiovaxID sooner than we could otherwise.
Initiating patient enrollment in our second Phase 3 trial is an important milestone for talabostat's development and the company overall," said Don Kiepert, President and CEO of Point Therapeutics, Inc.
Having accelerated enrollment in our ongoing Phase 3 trial, we are now planning a commercial facility to enable us to deliver BiovaxID to those who need it if BiovaxID is approved.
In the Phase 3 trial, approximately 800 patients will be randomly assigned to treatment with either TOCOSOL Paclitaxel or Taxol, and the effects of each drug on anti-tumor efficacy, tolerability and safety will be assessed.
In May 2004, the Company announced the approval of a treatment protocol in the United States allowing the Company to provide the Ceplene combination therapy to malignant melanoma patients under an expanded access program while the current Phase 3 trial is being completed.
In Maxim's Phase 3 trial, 320 AML patients in complete remission in Europe, North America, Israel, New Zealand and Australia were randomized to receive Ceplene plus IL-2 or the current standard-of-care (no treatment).
We believe in the approvability of our eCTD application based upon the most recent 36-month follow-up data from the MP-US-M01 Phase 3 trial (M01) in patients with advanced malignant melanoma coupled, with the single-arm MP-MA-0103 Phase 2 trial (M0103) reported earlier this year.
Maxim Pharmaceuticals (Nasdaq NM: MAXM, SSE: MAXM) announced that it has completed enrollment for the confirmatory Phase 3 trial of its lead drug candidate Ceplene(TM) (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) for the treatment of advanced malignant melanoma patients with liver metastases.