Výsledky vyhledávání - "William R. Prucka"

Onset and maintenance of efficacy of subcutaneous tanezumab in patients with moderate to severe osteoarthritis of the knee or hip: A 16-week dose-titration study

Autor: Louis Bessette, William R. Prucka, Leslie Tive, Glenn C. Pixton, Mark T. Brown, Christine R. West, Isabelle Davignon, Arifulla Khan, Thomas J. Schnitzer, Lars Viktrup

Publikováno v: Seminars in arthritis and rheumatism. 50(3)

Objective To examine the onset and maintenance of efficacy of subcutaneous tanezumab for pain relief and functional improvement in difficult-to-treat patients with moderate-to-severe osteoarthritis (OA) in a 16-week dose-titration study (NCT02697773)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fee118181b39dfcf04350b21b484d37e
https://pubmed.ncbi.nlm.nih.gov/32252976

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Sample Size Re-estimation Designs In Confirmatory Clinical Trials—Current State, Statistical Considerations, and Practical Guidance

Autor: William R. Prucka, Olga Marchenko, Ha Nguyen, Zoran Antonijevic, Yili L. Pritchett, Eva Miller, Matilde Sanchez-Kam, Caroline C. Morgan-Bouniol, Sandeep Menon

Publikováno v: Statistics in Biopharmaceutical Research. 7:309-321

A sample size re-estimation (SSR) design is a flexible, adaptive design with the primary purpose of allowing sample size of a study to be reassessed in the mid-course of the study to ensure adequate power. In real world drug product, biologic, and de

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::96104047b63076e11add104caff43957
https://doi.org/10.1080/19466315.2015.1098564

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Considerations for Using Positive Controls in Phase 2 Clinical Trials of Central Nervous System Disorders

Autor: Craig H. Mallinckrodt, William R. Prucka, Michael J. Detke, Geert Molenberghs, Stephen J. Ruberg

Publikováno v: Drug Information Journal. 44:431-441

Active comparators are often included in phase 2 studies as a positive control to assess assay sensitivity, but inclusion of a positive control does not necessarily improve decision making. Examples show that positive controls are more useful in asse

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94451a7e87229d6b5c6da6af540470b5
https://doi.org/10.1177/009286151004400407

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Results from clinical trials of a selective ionotropic glutamate receptor 5 (iGluR5) antagonist, LY5454694 tosylate, in 2 chronic pain conditions

Autor: Smriti Iyengar, William R. Prucka, Evelyn D. Lobo, Amy S. Chappell

Publikováno v: PainReferences. 155(6)

This article reports results of 2 studies investigating LY545694 in pain due to osteoarthritis (OA) of the knee and diabetic peripheral neuropathic pain (DPNP). Study I randomized patients to either of 2 doses of LY545694 or to placebo, and study II

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b1e6c49dba9a0bbfa14d780c70667244
https://pubmed.ncbi.nlm.nih.gov/24631589

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Considerations for Comparing a Test Drug With Standard of Care in Phase 2 Clinical Trials of Central Nervous System Disorders

Autor: Geert Molenberghs, Michael J. Detke, Craig H. Mallinckrodt, Stephen J. Ruberg, William R. Prucka

An increasing need exists to understand the benefits of a test drug compared with standard of care (SoC) earlier in development. Even if a drug is superior to placebo, it may not be worthwhile to continue development unless it has advantages over SoC

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::111ebce6ab44d9152f6d62668cf80f77
https://lirias.kuleuven.be/handle/123456789/286353

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Signal detection and placebo response in schizophrenia: parallels with depression

Autor: Craig H, Mallinckrodt, Lu, Zhang, William R, Prucka, Brian A, Millen

Publikováno v: Psychopharmacology bulletin. 43(1)

Placebo response and the rate of failed clinical trials are increasing in schizophrenia, resembling previous experience with antidepressant clinical trials. In depression, the percent of patients randomized to placebo was shown to be strongly associa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::8dda36c50e559e81c0074c918895b76b
https://pubmed.ncbi.nlm.nih.gov/20581800

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