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887 results on '"Raja, Srinivasa N."'

6. Human birth tissue products as a regenerative medicine to inhibit post-surgical pain through multi-modal action

Author

Zhang, Chi, primary, Huang, Qian, additional, Ford, Neil C., additional, Limjunyawong, Nathachit, additional, Lin, Qing, additional, Yang, Fei, additional, Cui, Xiang, additional, Uniyal, Ankit, additional, Liu, Jing, additional, Mahabole, Megha, additional, He, Hua, additional, Wang, Xue-Wei, additional, Duff, Irina, additional, Wang, Yiru, additional, Wan, Jieru, additional, Zhu, Guangwu, additional, Raja, Srinivasa N, additional, Jia, Hongpeng, additional, Yang, Dazhi, additional, Dong, Xinzhong, additional, Tseng, Scheffer C., additional, He, Shao-Qiu, additional, and Guan, Yun, additional

Published
2024
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10. Benefit–risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations

Author

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., OʼConnor, 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., and Wilson, Hilary D.

Published
2022
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12. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis

Author

Finnerup, Nanna B, Attal, Nadine, Haroutounian, Simon, McNicol, Ewan, Baron, Ralf, Dworkin, Robert H, Gilron, Ian, Haanpää, Maija, Hansson, Per, Jensen, Troels S, Kamerman, Peter R, Lund, Karen, Moore, Andrew, Raja, Srinivasa N, Rice, Andrew SC, Rowbotham, Michael, Sena, Emily, Siddall, Philip, Smith, Blair H, and Wallace, Mark

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Neurodegenerative, Peripheral Neuropathy, Neurosciences, Pain Research, Chronic Pain, Substance Misuse, Drug Abuse (NIDA only), Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Analgesics, Opioid, Antidepressive Agents, Tricyclic, Humans, Neuralgia, Pain Management, Randomized Controlled Trials as Topic, Clinical Sciences, Neurology & Neurosurgery
Abstract

BackgroundNew drug treatments, clinical trials, and standards of quality for assessment of evidence justify an update of evidence-based recommendations for the pharmacological treatment of neuropathic pain. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), we revised the Special Interest Group on Neuropathic Pain (NeuPSIG) recommendations for the pharmacotherapy of neuropathic pain based on the results of a systematic review and meta-analysis.MethodsBetween April, 2013, and January, 2014, NeuPSIG of the International Association for the Study of Pain did a systematic review and meta-analysis of randomised, double-blind studies of oral and topical pharmacotherapy for neuropathic pain, including studies published in peer-reviewed journals since January, 1966, and unpublished trials retrieved from ClinicalTrials.gov and websites of pharmaceutical companies. We used number needed to treat (NNT) for 50% pain relief as a primary measure and assessed publication bias; NNT was calculated with the fixed-effects Mantel-Haenszel method.Findings229 studies were included in the meta-analysis. Analysis of publication bias suggested a 10% overstatement of treatment effects. Studies published in peer-reviewed journals reported greater effects than did unpublished studies (r(2) 9·3%, p=0·009). Trial outcomes were generally modest: in particular, combined NNTs were 6·4 (95% CI 5·2-8·4) for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine (nine of 14 studies); 7·7 (6·5-9·4) for pregabalin; 7·2 (5·9-9·21) for gabapentin, including gabapentin extended release and enacarbil; and 10·6 (7·4-19·0) for capsaicin high-concentration patches. NNTs were lower for tricyclic antidepressants, strong opioids, tramadol, and botulinum toxin A, and undetermined for lidocaine patches. Based on GRADE, final quality of evidence was moderate or high for all treatments apart from lidocaine patches; tolerability and safety, and values and preferences were higher for topical drugs; and cost was lower for tricyclic antidepressants and tramadol. These findings permitted a strong recommendation for use and proposal as first-line treatment in neuropathic pain for tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, pregabalin, and gabapentin; a weak recommendation for use and proposal as second line for lidocaine patches, capsaicin high-concentration patches, and tramadol; and a weak recommendation for use and proposal as third line for strong opioids and botulinum toxin A. Topical agents and botulinum toxin A are recommended for peripheral neuropathic pain only.InterpretationOur results support a revision of the NeuPSIG recommendations for the pharmacotherapy of neuropathic pain. Inadequate response to drug treatments constitutes a substantial unmet need in patients with neuropathic pain. Modest efficacy, large placebo responses, heterogeneous diagnostic criteria, and poor phenotypic profiling probably account for moderate trial outcomes and should be taken into account in future studies.FundingNeuPSIG of the International Association for the Study of Pain.

Published
2015

14. Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations

Author

Gewandter, Jennifer S., Smith, Shannon M., Dworkin, Robert H., Turk, Dennis C., Gan, Tong J., Gilron, Ian, Hertz, Sharon, Katz, Nathaniel P., Markman, John D., Raja, Srinivasa N., Rowbotham, Michael C., Stacey, Brett R., Strain, Eric C., Ward, Denham S., Farrar, John T., Kroenke, Kurt, Rathmell, James P., Rauck, Richard, Brown, Colville, Cowan, Penney, Edwards, Robert R., Eisenach, James C., Ferguson, McKenzie, Freeman, Roy, Gray, Roy, Giblin, Kathryn, Grol-Prokopczyk, Hanna, Haythornthwaite, Jennifer, Jamison, Robert N., Martel, Marc, McNicol, Ewan, L. Oshinsky, Michael, Sandbrink, Friedhelm, Scholz, Joachim, Scranton, Richard, Simon, Lee S., Steiner, Deborah, Verburg, Kenneth, Wasan, Ajay D., and Wentworth, Kerry

Published
2021
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15. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

Author

Gewandter, Jennifer S, Dworkin, Robert H, Turk, Dennis C, McDermott, Michael P, Baron, Ralf, Gastonguay, Marc R, Gilron, Ian, Katz, Nathaniel P, Mehta, Cyrus, Raja, Srinivasa N, Senn, Stephen, Taylor, Charles, Cowan, Penney, Desjardins, Paul, Dimitrova, Rozalina, Dionne, Raymond, Farrar, John T, Hewitt, David J, Iyengar, Smriti, Jay, Gary W, Kalso, Eija, Kerns, Robert D, Leff, Richard, Leong, Michael, Petersen, Karin L, Ravina, Bernard M, Rauschkolb, Christine, Rice, Andrew SC, Rowbotham, Michael C, Sampaio, Cristina, Sindrup, Søren H, Stauffer, Joseph W, Steigerwald, Ilona, Stewart, Jonathan, Tobias, Jeffrey, Treede, Rolf-Detlef, Wallace, Mark, and White, Richard E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Pain Research, Clinical Trials and Supportive Activities, Clinical Research, Health and social care services research, 8.4 Research design and methodologies (health services), Generic health relevance, Chronic Pain, Clinical Trials as Topic, Humans, Research Design, Sample Size, Clinical trials, IMMPACT, Methodology, Proof of concept, Medical and Health Sciences, Psychology and Cognitive Sciences, Anesthesiology, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

Proof-of-concept (POC) clinical trials play an important role in developing novel treatments and determining whether existing treatments may be efficacious in broader populations of patients. The goal of most POC trials is to determine whether a treatment is likely to be efficacious for a given indication and thus whether it is worth investing the financial resources and participant exposure necessary for a confirmatory trial of that intervention. A challenge in designing POC trials is obtaining sufficient information to make this important go/no-go decision in a cost-effective manner. An IMMPACT consensus meeting was convened to discuss design considerations for POC trials in analgesia, with a focus on maximizing power with limited resources and participants. We present general design aspects to consider including patient population, active comparators and placebos, study power, pharmacokinetic-pharmacodynamic relationships, and minimization of missing data. Efficiency of single-dose studies for treatments with rapid onset is discussed. The trade-off between parallel-group and crossover designs with respect to overall sample sizes, trial duration, and applicability is summarized. The advantages and disadvantages of more recent trial designs, including N-of-1 designs, enriched designs, adaptive designs, and sequential parallel comparison designs, are summarized, and recommendations for consideration are provided. More attention to identifying efficient yet powerful designs for POC clinical trials of chronic pain treatments may increase the percentage of truly efficacious pain treatments that are advanced to confirmatory trials while decreasing the percentage of ineffective treatments that continue to be evaluated rather than abandoned.

Published
2014

18. Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

Author

Comer, Sandra D, Zacny, James P, Dworkin, Robert H, Turk, Dennis C, Bigelow, George E, Foltin, Richard W, Jasinski, Donald R, Sellers, Edward M, Adams, Edgar H, Balster, Robert, Burke, Laurie B, Cerny, Igor, Colucci, Robert D, Cone, Edward, Cowan, Penney, Farrar, John T, Haddox, David J, Haythornthwaite, Jennifer A, Hertz, Sharon, Jay, Gary W, Johanson, ChrisEllyn, Junor, Roderick, Katz, Nathaniel P, Klein, Michael, Kopecky, Ernest A, Leiderman, Deborah B, McDermott, Michael P, O’Brien, Charles, O’Connor, Alec B, Palmer, Pamela P, Raja, Srinivasa N, Rappaport, Bob A, Rauschkolb, Christine, Rowbotham, Michael C, Sampaio, Cristina, Setnik, Beatrice, Sokolowska, Marta, Stauffer, Joseph W, and Walsh, Sharon L

Subjects
Biomedical and Clinical Sciences, Biological Psychology, Clinical Sciences, Psychology, Pharmacology and Pharmaceutical Sciences, Pain Research, Substance Misuse, Neurosciences, Drug Abuse (NIDA only), Chronic Pain, Clinical Research, Mental health, Good Health and Well Being, Analgesics, Opioid, Clinical Trials as Topic, Humans, Internationality, Neurology, Opioid-Related Disorders, Outcome Assessment, Health Care, Practice Guidelines as Topic, Risk Assessment, Opioids, Opioid analgesics, Abuse, Abuse liability, Abuse potential, Medical and Health Sciences, Psychology and Cognitive Sciences, Anesthesiology, Biomedical and clinical sciences, Health sciences
Abstract

A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL have the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing the abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided, and those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are then discussed. These outcome measures include the following: subjective effects (some of which comprise the primary outcome measures, including drug liking; physiological responses; drug self-administration behavior; and cognitive and psychomotor performance. Before presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed.

Published
2012

19. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations

Author

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, and Walco, Gary A.

Published
2021
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20. Targeting human Mas-related G protein-coupled receptor X1 to inhibit persistent pain

Author

Li, Zhe, Tseng, Pang-Yen, Tiwari, Vinod, Xu, Qian, He, Shao-Qiu, Wang, Yan, Zheng, Qin, Han, Liang, Wu, Zhiping, Blobaum, Anna L., Cui, Yiyuan, Tiwari, Vineeta, Sun, Shuohao, Cheng, Yingying, Huang-Lionnet, Julie H. Y., Geng, Yixun, Xiao, Bo, Peng, Junmin, Hopkins, Corey, Raja, Srinivasa N., Guan, Yun, and Dong, Xinzhong

Published
2017

21. Injury-induced mechanical hypersensitivity requires C-low threshold mechanoreceptors.

Author

Seal, Rebecca P, Wang, Xidao, Guan, Yun, Raja, Srinivasa N, Woodbury, C Jeffery, Basbaum, Allan I, and Edwards, Robert H

Subjects
Ganglia, Spinal, Mechanoreceptors, Animals, Mice, Inbred C57BL, Mice, Knockout, Mice, Pain, Hypersensitivity, Wounds and Injuries, Amino Acid Transport Systems, Acidic, Behavior, Animal, Gene Expression Regulation, Female, Amino Acid Transport Systems, Acidic, Behavior, Animal, Ganglia, Spinal, Inbred C57BL, Knockout, General Science & Technology
Abstract

Mechanical pain contributes to the morbidity associated with inflammation and trauma, but primary sensory neurons that convey the sensation of acute and persistent mechanical pain have not been identified. Dorsal root ganglion (DRG) neurons transmit sensory information to the spinal cord using the excitatory transmitter glutamate, a process that depends on glutamate transport into synaptic vesicles for regulated exocytotic release. Here we report that a small subset of cells in the DRG expresses the low abundance vesicular glutamate transporter VGLUT3 (also known as SLC17A8). In the dorsal horn of the spinal cord, these afferents project to lamina I and the innermost layer of lamina II, which has previously been implicated in persistent pain caused by injury. Because the different VGLUT isoforms generally have a non-redundant pattern of expression, we used Vglut3 knockout mice to assess the role of VGLUT3(+) primary afferents in the behavioural response to somatosensory input. The loss of VGLUT3 specifically impairs mechanical pain sensation, and in particular the mechanical hypersensitivity to normally innocuous stimuli that accompanies inflammation, nerve injury and trauma. Direct recording from VGLUT3(+) neurons in the DRG further identifies them as a poorly understood population of unmyelinated, low threshold mechanoreceptors (C-LTMRs). The analysis of Vglut3(-/-) mice now indicates a critical role for C-LTMRs in the mechanical hypersensitivity caused by injury.

Published
2009

23. The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations

Author

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., and Witter, James

Published
2017
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34. The IASP classification of chronic pain for ICD-11: chronic neuropathic pain

Author

Scholz, Joachim, Finnerup, Nanna B., Attal, Nadine, Aziz, Qasim, Baron, Ralf, Bennett, Michael I., Benoliel, Rafael, Cohen, Milton, Cruccu, Giorgio, Davis, Karen D., Evers, Stefan, First, Michael, Giamberardino, Maria Adele, Hansson, Per, Kaasa, Stein, Korwisi, Beatrice, Kosek, Eva, Lavandʼhomme, Patricia, Nicholas, Michael, Nurmikko, Turo, Perrot, Serge, Raja, Srinivasa N., Rice, Andrew S.C., Rowbotham, Michael C., Schug, Stephan, Simpson, David M., Smith, Blair H., Svensson, Peter, Vlaeyen, Johan W.S., Wang, Shuu-Jiun, Barke, Antonia, Rief, Winfried, and Treede, Rolf-Detlef

Published
2019
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35. List of Contributors

Author

Abdel-Aziz, Samer, primary, Adams, Meredith C.B., additional, Ahmed, Moustafa, additional, Al-Qamari, Abbas, additional, Anitescu, Magdalena, additional, Asenjo, Juan Francisco, additional, Ault, Michael Lynn, additional, Bauchat, Jeanette, additional, Beckerly, Rena, additional, Belvis, Dawn, additional, Benzon, Honorio T., additional, Benzon, Hubert A., additional, Berde, Charles B., additional, Bhatia, Anuj, additional, Bhayani, Sadiq, additional, Bicket, Mark C., additional, Birmingham, Patrick K., additional, Boyette-Davis, Jessica, additional, Brannagan, Thomas H., additional, Brummett, Chad, additional, Camacho-Soto, Alejandra, additional, Chekka, Kiran, additional, Christiansen, Sandy, additional, Chung, Brian A., additional, Clark, Michael R., additional, Clauw, Daniel J., additional, Cohen, Marc Samuel, additional, Cohen, Steven P., additional, Conlin, Nikki, additional, Crooks, Matthew, additional, Day, Miles, additional, DeCaria, Sheetal K., additional, Deer, Timothy R., additional, Dougherty, Patrick M., additional, Durbhakula, Shravani, additional, Dworkin, Robert H., additional, Edwards, Robert R., additional, Elbaridi, Nick, additional, Endrizzi, Sarah A., additional, Erdek, Michael, additional, Ferrante, F. Michael, additional, Finnerup, Nanna Brix, additional, Flamer, David, additional, Furnish, Timothy J., additional, Gilson, Aaron M., additional, Gofeld, Michael, additional, Grant, Michael C., additional, Gritsenko, Karina, additional, Guarino, Anthony, additional, Halawa, Omar I., additional, Hale, Charity, additional, Hameed, Haroon, additional, Hameed, Mariam, additional, Hanes, Michael C., additional, Haroutounian, Simon, additional, Haythornthwaite, Jennifer, additional, Henderson, Kimberly J., additional, Hernandez, Gabriel A., additional, Hobelmann, J. Gregory, additional, Holtsman, Mark, additional, Hosey, Megan, additional, Hsu, Eric S., additional, Huang-Lionnet, Julie H., additional, Huntoon, Marc Alan, additional, Hurley, Robert W., additional, Ilfeld, Brian M., additional, Issa, Mohammed A., additional, Jacobs, Michael B., additional, Jamison, David E., additional, Justiz, Rafael, additional, Khan, Dost, additional, Krodel, David J., additional, Lai, Brian, additional, Lazaridou, Asimina, additional, Lerman, Sheera F., additional, Liu, Benjamin P., additional, Liu, Spencer S., additional, Lookabaugh, Britni L., additional, Mahajan, Gagan, additional, Malik, Khalid, additional, Mariano, Edward R., additional, Marshall, Zwade, additional, Mathews, James, additional, McCartney, Colin J.L., additional, McWhorter, Jessica Wolfman, additional, Minieka, Michael M., additional, Moore, Arthur, additional, Nader, Antoun, additional, Narouze, Samer, additional, Nelson, Ariana, additional, Nicol, Andrea L., additional, Nishida, Takashi, additional, Nouri, Kent H., additional, Osuagwu, Uzondu, additional, Paice, Judith A., additional, Peng, Philip, additional, Peterson, Stacy, additional, Pope, Jason E., additional, Prather, Heidi, additional, Press, Joel, additional, Provenzano, David A., additional, Rahangdale, Rohit, additional, Raja, Srinivasa N., additional, Rathmell, James P., additional, Rich, Ben A., additional, Ringkamp, Matthias, additional, Rivers, W. Evan, additional, Rodes, Meghan, additional, Rosenow, Joshua, additional, Rozental, Jack M., additional, Russell, Eric J., additional, Rydberg, Leslie, additional, Saeed, Kashif, additional, Schmader, Kenneth, additional, Scholten, Paul, additional, Shah, Ravi D., additional, Shankar, Hariharan, additional, Sheth, Samir, additional, Soffin, Ellen M., additional, Sowa, Gwendolyn A., additional, Spitzer, Eric M., additional, Spofford, Christina M., additional, Stacey, Brett, additional, Stanos, Steven P., additional, Suresh, Santhanam, additional, Tremblay, Steven, additional, Tureanu, Luminita, additional, Van Buyten, Jean Pierre, additional, Veeramani, Murugusundaram, additional, Von Gunten, Charles F., additional, Walega, David Richard, additional, Walker, Matthew T., additional, Wallace, Mark S., additional, Wasan, Ajay D., additional, Webster, Lynn R., additional, Wegener, Stephen T., additional, Weiner, Debra K., additional, Wilkinson, Indy, additional, Williams, Bryan S., additional, Williams, Kayode, additional, Wong, Cynthia A., additional, Wu, Christopher L., additional, Wu, Irene, additional, Wu, Jiang, additional, and Zheng, Sophy C., additional

Published
2018
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40. Dedication

Author

Benzon, Honorio T., primary, Raja, Srinivasa N., additional, Liu, Spencer S., additional, Fishman, Scott M., additional, Cohen, Steven P., additional, Hurley, Robert W., additional, Malik, Khalid, additional, and Peng, Philip, additional

Published
2018
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