Search Results - "Kopecky, Ernest A"

Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and recommendations by Smith, Shannon M., Dart, Richard C., Katz, Nathaniel P., Paillard, Florence, Adams, Edgar H., Comer, Sandra D., Degroot, Aldemar, Edwards, Robert R., Haddox, J. David, Jaffe, Jerome H., Jones, Christopher M., Kleber, Herbert D., Kopecky, Ernest A., Markman, John D., Montoya, Ivan D., O’Brien, Charles, Roland, Carl L., Stanton, Marsha, Strain, Eric C., Vorsanger, Gary, Wasan, Ajay D., Weiss, Roger D., Turk, Dennis C., Dworkin, Robert H.

“…Terminology related to prescription drug misuse and abuse is inconsistently defined. An expert panel developed consensus classifications and definitions for…”
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Opioid Pharmacology: Developmental Effects on Opioid Metabolism by Kopecky, Ernest A

“…AIMS/OBJECTIVES/BACKGROUND:Children represent a patient demographic composed of multiple, unique subpopulations differentiated by rapidly changing age-related…”
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Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations by Gewandter, Jennifer S., Dworkin, Robert H., Turk, Dennis C., Farrar, John T., Fillingim, Roger B., Gilron, Ian, Markman, John D., Oaklander, Anne Louise, Polydefkis, Michael J., Raja, Srinivasa N., Robinson, James P., Woolf, Clifford J., Ziegler, Dan, Ashburn, Michael A., Burke, Laurie B., Cowan, Penney, George, Steven Z., Goli, Veeraindar, Graff, Ole X., Iyengar, Smriti, Jay, Gary W., Katz, Joel, Kehlet, Henrik, Kitt, Rachel A., Kopecky, Ernest A., Malamut, Richard, McDermott, Michael P., Palmer, Pamela, Rappaport, Bob A., Rauschkolb, Christine, Steigerwald, Ilona, Tobias, Jeffrey, Walco, Gary A.

“…Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been…”
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Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations by Smith, Shannon M., Dworkin, Robert H., Turk, Dennis C., McDermott, Michael P., Eccleston, Christopher, Farrar, John T., Rowbotham, Michael C., Bhagwagar, Zubin, Burke, Laurie B., Cowan, Penney, Ellenberg, Susan S., Evans, Scott R., Freeman, Roy L., Garrison, Louis P., Iyengar, Smriti, Jadad, Alejandro, Jensen, Mark P., Junor, Roderick, Kamp, Cornelia, Katz, Nathaniel P., Kesslak, James Patrick, Kopecky, Ernest A., Lissin, Dmitri, Markman, John D., Mease, Philip J., O'Connor, Alec B., Patel, Kushang V., Raja, Srinivasa N., Sampaio, Cristina, Schoenfeld, David, Singh, Jasvinder, Steigerwald, Ilona, Strand, Vibeke, Tive, Leslie A., Tobias, Jeffrey, Wasan, Ajay D., Wilson, Hilary D.

“…Copyright © 2020 International Association for the Study of Pain. Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the…”
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Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations by Edwards, Robert R., Dworkin, Robert H., Turk, Dennis C., Angst, Martin S., Dionne, Raymond, Freeman, Roy, Hansson, Per, Haroutounian, Simon, Arendt-Nielsen, Lars, Attal, Nadine, Baron, Ralf, Brell, Joanna, Bujanover, Shay, Burke, Laurie B., Carr, Daniel, Chappell, Amy S., Cowan, Penney, Etropolski, Mila, Fillingim, Roger B., Gewandter, Jennifer S., Katz, Nathaniel P., Kopecky, Ernest A., Markman, John D., Nomikos, George, Porter, Linda, Rappaport, Bob A., Rice, Andrew S.C., Scavone, Joseph M., Scholz, Joachim, Simon, Lee S., Smith, Shannon M., Tobias, Jeffrey, Tockarshewsky, Tina, Veasley, Christine, Versavel, Mark, Wasan, Ajay D., Wen, Warren, Yarnitsky, David

“…There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great…”
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Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations by Taylor, Ann M., Phillips, Kristine, Patel, Kushang V., Turk, Dennis C., Dworkin, Robert H., Beaton, Dorcas, Clauw, Daniel J., Gignac, Monique A.M., Markman, John D., Williams, David A., Bujanover, Shay, Burke, Laurie B., Carr, Daniel B., Choy, Ernest H., Conaghan, Philip G., Cowan, Penney, Farrar, John T., Freeman, Roy, Gewandter, Jennifer, Gilron, Ian, Goli, Veeraindar, Gover, Tony D., Haddox, J. David, Kerns, Robert D., Kopecky, Ernest A., Lee, David A., Malamut, Richard, Mease, Philip, Rappaport, Bob A., Simon, Lee S., Singh, Jasvinder A., Smith, Shannon M., Strand, Vibeke, Tugwell, Peter, Vanhove, Gertrude F., Veasley, Christin, Walco, Gary A., Wasan, Ajay D., Witter, James

“…Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing…”
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The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations by Smith, Shannon M, Dworkin, Robert H, Turk, Dennis C, Baron, Ralf, Polydefkis, Michael, Tracey, Irene, Borsook, David, Edwards, Robert R, Harris, Richard E, Wager, Tor D, Arendt-Nielsen, Lars, Burke, Laurie B, Carr, Daniel B, Chappell, Amy, Farrar, John T, Freeman, Roy, Gilron, Ian, Goli, Veeraindar, Haeussler, Juergen, Jensen, Troels, Katz, Nathaniel P, Kent, Jeffrey, Kopecky, Ernest A, Lee, David A, Maixner, William, Markman, John D, McArthur, Justin C, McDermott, Michael P, Parvathenani, Lav, Raja, Srinivasa N, Rappaport, Bob A, Rice, Andrew S C, Rowbotham, Michael C, Tobias, Jeffrey K, Wasan, Ajay D, Witter, James

“…Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment…”
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Tolerability, Safety, and Effectiveness of Oxycodone DETERx in Elderly Patients ≥65 Years of Age with Chronic Low Back Pain: A Randomized Controlled Trial by Kopecky, Ernest A., Vaughn, Ben, Lagasse, Scott, O’Connor, Melinda

“…Trial Design This was a phase III, randomized withdrawal, double-blind, placebo-controlled, enriched enrollment, parallel-group, multicenter study intended to…”
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Oral Human Abuse Potential of Oxycodone DETERx® (Xtampza® ER) by Kopecky, Ernest A., Fleming, Alison B., Levy‐Cooperman, Naama, O'Connor, Melinda, M. Sellers, Edward

“…Oxycodone DETERx® (Collegium Pharmaceutical Inc, Canton, Massachusetts) is an extended‐release, microsphere‐in‐capsule, abuse‐deterrent formulation designed to…”
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Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations by Gewandter, Jennifer S., Dworkin, Robert H., Turk, Dennis C., Farrar, John T., Fillingim, Roger B., Gilron, Ian, Markman, John D., Oaklander, Anne Louise, Polydefkis, Michael J., Raja, Srinivasa N., Robinson, James P., Woolf, Clifford J., Ziegler, Dan, Ashburn, Michael A., Burke, Laurie B., Cowan, Penney, George, Steven Z., Goli, Veeraindar, Graff, Ole X., Iyengar, Smriti, Jay, Gary W., Katz, Joel, Kehlet, Henrik, Kitt, Rachel A., Kopecky, Ernest A., Malamut, Richard, McDermott, Michael P., Palmer, Pamela, Rappaport, Bob A., Rauschkolb, Christine, Steigerwald, Ilona, Tobias, Jeffrey, Walco, Gary A.

“…Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been…”
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Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations by Dworkin, Robert H., Turk, Dennis C., Peirce-Sandner, Sarah, Burke, Laurie B., Farrar, John T., Gilron, Ian, Jensen, Mark P., Katz, Nathaniel P., Raja, Srinivasa N., Rappaport, Bob A., Rowbotham, Michael C., Backonja, Misha-Miroslav, Baron, Ralf, Bellamy, Nicholas, Bhagwagar, Zubin, Costello, Ann, Cowan, Penney, Fang, Weikai Christopher, Hertz, Sharon, Jay, Gary W., Junor, Roderick, Kerns, Robert D., Kerwin, Rosemary, Kopecky, Ernest A., Lissin, Dmitri, Malamut, Richard, Markman, John D., McDermott, Michael P., Munera, Catherine, Porter, Linda, Rauschkolb, Christine, Rice, Andrew S.C., Sampaio, Cristina, Skljarevski, Vladimir, Sommerville, Kenneth, Stacey, Brett R., Steigerwald, Ilona, Tobias, Jeffrey, Trentacosti, Ann Marie, Wasan, Ajay D., Wells, George A., Williams, Jim, Witter, James, Ziegler, Dan

“…A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo…”
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Impact of physical manipulation on in vitro and in vivo release profiles of oxycodone DETERx®: an extended-release, abuse-deterrent formulation by Kopecky, Ernest A, Fleming, Alison B, Noonan, Patrick K, Varanasi, Ravi K, Grima, Michael, Saim, Said, Mayock, Stephen P

“…In vitro: To assess the effect of common crushing techniques on particle size reduction (PSR) and in vitro drug-release kinetics of oxycodone DETERx® (herein…”
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A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain by Katz, Nathaniel, Kopecky, Ernest A., O'Connor, Melinda, Brown, Robert H., Fleming, Alison B.

“…Opioid analgesics are commonly used for the treatment of chronic low back pain (CLBP); however, abuse potential is a major concern. This study used a…”
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Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations by Gewandter, Jennifer S, Dworkin, Robert H, Turk, Dennis C, Devine, Eric G, Hewitt, David, Jensen, Mark P, Katz, Nathaniel P, Kirkwood, Amy A, Malamut, Richard, Markman, John D, Vrijens, Bernard, Burke, Laurie, Campbell, James N, Carr, Daniel B, Conaghan, Philip G, Cowan, Penney, Doyle, Mittie K, Edwards, Robert R, Evans, Scott R, Farrar, John T, Freeman, Roy, Gilron, Ian, Juge, Dean, Kerns, Robert D, Kopecky, Ernest A, McDermott, Michael P, Niebler, Gwendolyn, Patel, Kushang V, Rauck, Richard, Rice, Andrew S C, Rowbotham, Michael, Sessler, Nelson E, Simon, Lee S, Singla, Neil, Skljarevski, Vladimir, Tockarshewsky, Tina, Vanhove, Geertrui F, Wasan, Ajay D, Witter, James

“…The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable…”
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Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended‐Release Oxycodone Formulations with Abuse‐Deterrent Properties by Gudin, Jeff, Levy‐Cooperman, Naama, Kopecky, Ernest A., Fleming, Alison B.

“…Objective Oxycodone DETERx® is an extended‐release (ER), microsphere‐in‐capsule abuse‐deterrent‐formulation designed to retain its extended‐release properties…”
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Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system by Smith, Shannon M., Amtmann, Dagmar, Askew, Robert L., Gewandter, Jennifer S., Hunsinger, Matthew, Jensen, Mark P., McDermott, Michael P., Patel, Kushang V., Williams, Mark, Bacci, Elizabeth D., Burke, Laurie B., Chambers, Christine T., Cooper, Stephen A., Cowan, Penney, Desjardins, Paul, Etropolski, Mila, Farrar, John T., Gilron, Ian, Huang, I-zu, Katz, Mitchell, Kerns, Robert D., Kopecky, Ernest A., Rappaport, Bob A., Resnick, Malca, Strand, Vibeke, Vanhove, Geertrui F., Veasley, Christin, Versavel, Mark, Wasan, Ajay D., Turk, Dennis C., Dworkin, Robert H.

“…Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes…”
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Benefit–risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations by Kleykamp, Bethea A., Dworkin, Robert H., Turk, Dennis C., Bhagwagar, Zubin, Cowan, Penney, Eccleston, Christopher, Ellenberg, Susan S., Evans, Scott R., Farrar, John T., Freeman, Roy L., Garrison, Louis P., Gewandter, Jennifer S., Goli, Veeraindar, Iyengar, Smriti, Jadad, Alejandro R., Jensen, Mark P., Junor, Roderick, Katz, Nathaniel P., Kesslak, J. Patrick, Kopecky, Ernest A., Lissin, Dmitri, Markman, John D., McDermott, Michael P., Mease, Philip J., O'Connor, Alec B., Patel, Kushang V., Raja, Srinivasa N., Rowbotham, Michael C., Sampaio, Cristina, Singh, Jasvinder A., Steigerwald, Ilona, Strand, Vibeke, Tive, Leslie A., Tobias, Jeffrey, Wasan, Ajay D., Wilson, Hilary D.

“…Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite…”
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A Randomized, Double-Blind, Double-Dummy Study to Evaluate the Intranasal Human Abuse Potential and Pharmacokinetics of a Novel Extended-Release Abuse-Deterrent Formulation of Oxycodone by Webster, Lynn R., Kopecky, Ernest A., Smith, Michael D., Fleming, Alison B.

“…Abstract Objective. Evaluate the human abuse potential (HAP) of an experimental, microsphere-in-capsule formulation of extended-release oxycodone (oxycodone…”
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Patients with chronic pain and dysphagia (CPD): unmet medical needs and pharmacologic treatment options by Argoff, Charles E., Kopecky, Ernest A.

“…Abstract Background: For properly selected patients experiencing chronic pain, extended-release opioid formulations may represent an appropriate pain…”
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Clinical trial designs and models for analgesic medications for acute pain in neonates, infants, toddlers, children, and adolescents: ACTTION recommendations by Walco, Gary A., Kopecky, Ernest A., Weisman, Steven J., Stinson, Jennifer, Stevens, Bonnie, Desjardins, Paul J., Berde, Charles B., Krane, Elliot J., Anand, Kanwaljeet J.S., Yaster, Myron, Dampier, Carlton D., Dworkin, Robert H., Gilron, Ian, Lynn, Anne M., Maxwell, Lynne G., Raja, Srinivasa, Schachtel, Bernard, Turk, Dennis C.

“…Clinical trials to test the safety and efficacy of analgesics across all pediatric age cohorts are needed to avoid inappropriate extrapolation of adult data to…”
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