Definitions
from The American Heritage® Dictionary of the English Language, 5th Edition.
- adjective Of or related to a clinical trial in which both the researcher and the participant know whether an administered treatment is an experimental drug or a placebo.
Etymologies
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Examples
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Although several open-label trials on gene therapy have shown promise in treating neurologic disease, the researchers noted that this is the first of its type to be confirmed in a follow-up randomized double-blind trial, a study in which neither the investigators nor the patients knew which patients were receiving the real or sham treatment.
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Announcing the failure of the latest trial Tuesday, the two companies said they would halt development of Dimebon for all indications and cease an ongoing open-label extension study in Alzheimer's disease.
Medivation, Pfizer End Work on Alzheimer's Drug Jonathan D. Rockoff 2012
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Although several open-label trials on gene therapy have shown promise in treating neurologic disease, the researchers noted that this is the first of its type to be confirmed in a follow-up randomized double-blind trial, a study in which neither the investigators nor the patients knew which patients were receiving the real or sham treatment.
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“Placebo effect is an enormous problem in open-label studies,” said Dr. Scott Turner, incoming director of the Memory Disorders Program at Georgetown University Medical Center in Washington.
Drug restores speech in Alzheimer’s; experts worry « Isegoria 2008
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"Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial"
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It is in pursuant of these goals that MSD is sponsoring an expanded access, non-comparative, multi-centre, open-label, treatment use study titled "Early Access of MK-0518 in Combination With an Optimised Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options."
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Now, data from an open-label extension, which means that doctors and patients know which drugs are being used, show that those benefits continued after six months with no additional side effects.
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Tenthoff suggested that higher patient drop-outs may be due to the open-label nature of the trial.
Human Genome Sciences Seen Partnering Hep C Drug In 2006 2006
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On Monday morning, the biotech company said results from an ongoing open-label study showed 75% of patients taking the three main constituents of combo pill Atripla maintained a viral load below 400 copies of HIV per milliliter of blood, compared with 62% for patients taking a similar drug marketed by GlaxoSmithKline.
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"The focus for the stock, however, remains the potential launch of Tysabri, and our belief that this drug is likely to return to the market in the second quarter was bolstered by Wednesday's announcement that an open-label, safety extension study for the Phase III multiple sclerosis study could begin enrolling in the coming weeks," wrote analyst Steven Harr, in a client note.
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