LYCOS RETRIEVER 
Trial: Patients
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The first step in this trial is to establish the baseline frequency and severity of CMI for all study patients. Next, all patients receive granulocyte colony stimulating factor to mobilize the hematopoietic (blood- forming) CD34+ cells from their bone marrow to their bloodstream. Then, a cell separation system collects a mononuclear cell preparation rich in CD34+ stem cells from the patient's bloodstream. In the fourth step, Baxter's ISOLEX 300i Magnetic Cell Selection System selects the CD34+ stem cells that will be used in the investigational therapy. Interventional cardiologists then use a catheter-based, non-surgical system to inject the selected CD34+ cells into the areas of the heart that have poor blood flow. Researchers will conduct follow-up examinations with the patients for 12 months following the injection of their stem cells.
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Ingelheim, Germany (ots/PRNewswire) - - Trial to compare newest protease inhibitors in treatment-experienced patients with resistance to more than one PI Boehringer Ingelheim GmbH announced today that enrollment of the POTENT study will begin in August 2007. POTENT will compare the efficacy and safety of Aptivus(R) (tipranavir) versus darunavir, both with ritonavir as part of combination antiretroviral therapy. POTENT will include 800 treatment- experienced patients in 15 countries. The primary endpoint is time to virologic failure, with a secondary endpoint of virologic response at 48 weeks of treatment. In the ongoing RESIST trials, APTIVUS demonstrated superior virologic and immunologic responses versus a comparator group of protease inhibitors in highly treatment-experienced patients through 96 weeks of therapy (p<0.001).(1) The POTENT study will be the first head-to-head study comparing APTIVUS to another protease inhibitor developed specifically for treatment-experienced patients with HIV resistant to multiple agents in the protease inhibitor class. "Treatment-experienced patients need active treatment options to help achieve and maintain undetectable viral load.
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The POSIDUR Phase IIb clinical trial was designed to evaluate the tolerability, activity, dose response and pharmacokinetics of POSIDUR in patients undergoing open inguinal hernia repair. The study was conducted in Australia and New Zealand as a multi-center, randomized, double blind, placebo-controlled study in 122 patients. Study patients were randomized into three treatment groups: patients that were treated with POSIDUR 2.5 mL (n=43), POSIDUR 5 mL (n=47) and placebo (n=32). The co-primary efficacy endpoints for the study were Mean Pain Intensity on Movement area under the curve (AUC), a measure of pain over a period of time, 1-72 hours post-surgery, and the proportion of patients requiring supplemental opioid analgesic medication during the study. Secondary efficacy endpoints included Mean Pain Intensity on Movement AUC over the period 1-48 hours post-surgery, mean total consumption of supplemental opioid analgesic medication, and time to first use of supplemental opioid analgesic medication. The threshold for statistical significance was considered to be at the p
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SALT LAKE CITY, Aug. 2 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc. (Nasdaq: MYGN), announced today that enrollment in its Phase 3 trial of Flurizan™ in patients with mild stages of Alzheimer's disease is proceeding on schedule. The Company's amended protocol was reviewed by the FDA without any changes or request for modification and the central Investigational Review Board covering a majority of the investigational sites has given its approval of the modified protocol. More than 120 sites across the United States have been enlisted and most are now screening and enrolling patients into the study. Myriad anticipates completing enrollment for the 12-month study during the first half of 2006 and reporting the results of the Phase 3 trial in the third calendar quarter of 2007.
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PRNewswire-First Call via COMTEX/ -- DURECT Corporation (Nasdaq: DRRX) announced today positive results from a 122 patient Phase IIb clinical trial of POSIDUR™ for treatment of post-operative pain in patients undergoing inguinal hernia repair. This Phase IIb trial was designed to be the study upon which DURECT and its collaborator Nycomed would base their decision for advancing POSIDUR into Phase III clinical trials. In the trial, POSIDUR demonstrated statistically significant reductions in pain and total consumption of supplemental opioid analgesic medications versus placebo. These successful results trigger an $8 million milestone payment to be made by Nycomed to DURECT under the parties’ collaborative agreement. In preparation for the Phase III program, DURECT has scheduled an end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA).
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The multicenter trial involved 202 patients who were randomly assigned to two groups. One group received comprehensive medical management (CMM) for their pain. CMM is a more systematic approach to pain control than cancer patients typically receive. It involves a team of health care professionals with special training in pain management who search for the most effective pain medication for each patient by starting with the least toxic and only gradually moving up to medications with more side effects until the pain is relieved. CMM may ... include the use of complementary methods of pain reduction such as relaxation, guided imagery, psychotherapy, and patient support groups.
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