Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations
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Richard E. White | M. Rowbotham | E. Kalso | R. Treede | J. Farrar | S. Senn | R. Dworkin | R. Baron | B. Ravina | D. Turk | C. Sampaio | S. Raja | M. Mcdermott | S. Iyengar | R. Kerns | S. Sindrup | A. Rice | P. Cowan | K. Petersen | M. Wallace | M. Gastonguay | D. Hewitt | I. Gilron | M. Leong | J. Gewandter | Nathaniel Katz | C. Mehta | C. Taylor | P. Desjardins | R. Dimitrova | R. Dionne | G. Jay | Richard Leff | C. Rauschkolb | Joseph W. Stauffer | I. Steigerwald | Jonathan Stewart | J. Tobias | R. Leff | J. Stewart
[1] J. Jordan,et al. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. , 2014, Seminars in arthritis and rheumatism.
[2] R. Dworkin,et al. EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial , 2014, The Lancet.
[3] J. Farrar,et al. Interpreting patient treatment response in analgesic clinical trials: Implications for genotyping, phenotyping, and personalized pain treatment , 2014, PAIN®.
[4] L. Kux. OF HEALTH AND HUMAN SERVICES Food and Drug Administration , 2014 .
[5] C. Wade,et al. An innovative acupuncture treatment for primary dysmenorrhea: a randomized, crossover pilot study. , 2014, Alternative therapies in health and medicine.
[6] R. Freeman,et al. Value of quantitative sensory testing in neurological and pain disorders: NeuPSIG consensus , 2013, PAIN®.
[7] R. Gross. Spotlight on the July 2 Issue , 2013, Neurology.
[8] M. Rowbotham,et al. Assay sensitivity and study features in neuropathic pain trials , 2013, Neurology.
[9] Blair H. Smith,et al. Can pragmatic trials help us better understand chronic pain and improve treatment? , 2013, Pain.
[10] R. Shelton,et al. A 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. , 2012, The Journal of clinical psychiatry.
[11] R. Little,et al. The design and conduct of clinical trials to limit missing data , 2012, Statistics in medicine.
[12] Elizabeth D. Dalton,et al. L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials. , 2012, The American journal of psychiatry.
[13] R. Little,et al. The prevention and treatment of missing data in clinical trials. , 2012, The New England journal of medicine.
[14] D. Grobbee,et al. Increasing trial efficiency by early reallocation of placebo nonresponders in sequential parallel comparison designs: Application to antidepressant trials , 2012, Clinical trials.
[15] T. Smart,et al. An efficient randomised, placebo-controlled clinical trial with the irreversible fatty acid amide hydrolase-1 inhibitor PF-04457845, which modulates endocannabinoids but fails to induce effective analgesia in patients with pain due to osteoarthritis of the knee , 2012, PAIN®.
[16] D. Price,et al. Viscerosomatic facilitation in a subset of IBS patients, an effect mediated by N-methyl-D-aspartate receptors. , 2012, The journal of pain : official journal of the American Pain Society.
[17] T. Smart,et al. Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study , 2012, Journal of pain research.
[18] F. Miller,et al. Early phase drug development for treatment of chronic pain--options for clinical trial and program design. , 2012, Contemporary clinical trials.
[19] M. Rowbotham,et al. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations , 2012, PAIN.
[20] K. Bär,et al. [Drug therapy of fibromyalgia syndrome. Systematic review, meta-analysis and guideline]. , 2012, Schmerz.
[21] M. Rowbotham,et al. Efficacy and safety of the α4β2 neuronal nicotinic receptor agonist ABT-894 in patients with diabetic peripheral neuropathic pain , 2012, PAIN®.
[22] Gordon Guyatt,et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee , 2012, Arthritis care & research.
[23] C. Eccleston,et al. Estimate at your peril: Imputation methods for patient withdrawal can bias efficacy outcomes in chronic pain trials using responder analyses , 2012, PAIN.
[24] M. Pencina,et al. A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy among Depressed Outpatients with Inadequate Response to Prior Antidepressant Therapy (ADAPT-A Study) , 2012, Psychotherapy and Psychosomatics.
[25] F. Petzke,et al. Medikamentöse Therapie des Fibromyalgiesyndroms , 2008, Der Schmerz.
[26] Robert L. Becker,et al. Contains Nonbinding Recommendations Draft – Not for Implementation Guidance for Industry Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products , 2012 .
[27] W. Rief,et al. Mechanisms Involved in Placebo and Nocebo Responses and Implications for Drug Trials , 2011, Clinical pharmacology and therapeutics.
[28] Erik Olofsen,et al. Pharmacokinetic–pharmacodynamic modeling in acute and chronic pain: an overview of the recent literature , 2011, Expert review of clinical pharmacology.
[29] C. Birbara,et al. Efficacy and safety of tanezumab in the treatment of chronic low back pain , 2011, PAIN®.
[30] L. Aarts,et al. Absence of long‐term analgesic effect from a short‐term S‐ketamine infusion on fibromyalgia pain: A randomized, prospective, double blind, active placebo‐controlled trial , 2011, European journal of pain.
[31] K. Bley,et al. Topical capsaicin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch , 2011, British journal of anaesthesia.
[32] R. Kravitz,et al. N-of-1 Trials in the Medical Literature: A Systematic Review , 2011, Medical care.
[33] B. Schachtel,et al. Efficacy of low-dose celecoxib in patients with acute pain. , 2011, The journal of pain : official journal of the American Pain Society.
[34] Malcolm Rowland,et al. Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug response , 2011, Nature Reviews Drug Discovery.
[35] M. Magnin,et al. On the importance of placebo timing in rTMS studies for pain relief , 2011, PAIN.
[36] Wendy R. Sanhai,et al. Evidence-based clinical trial design for chronic pain pharmacotherapy: A blueprint for ACTION , 2011, PAIN.
[37] B. Galer,et al. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain , 2011, PAIN®.
[38] S. Daniels,et al. A randomised, five-parallel-group, placebo-controlled trial comparing the efficacy and tolerability of analgesic combinations including a novel single-tablet combination of ibuprofen/paracetamol for postoperative dental pain , 2011, PAIN®.
[39] Marieke Niesters,et al. Population pharmacokinetic—pharmacodynamic modeling of ketamine‐induced pain relief of chronic pain , 2011, European journal of pain.
[40] T. Fleming. Addressing Missing Data in Clinical Trials , 2011, Annals of Internal Medicine.
[41] Blair H. Smith,et al. NeuPSIG guidelines on neuropathic pain assessment , 2011, PAIN®.
[42] E. Irvin,et al. A comparison between enriched and nonenriched enrollment randomized withdrawal trials of opioids for chronic noncancer pain. , 2011, Pain research & management.
[43] R. Temple,et al. Enrichment of Clinical Study Populations , 2010, Clinical pharmacology and therapeutics.
[44] C. Eccleston,et al. “Evidence” in chronic pain – establishing best practice in the reporting of systematic reviews , 2010, PAIN.
[45] T. Nurmikko,et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision , 2010, European journal of neurology.
[46] Christine M. Micheel,et al. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease , 2010 .
[47] Richard E. White,et al. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations , 2010, PAIN®.
[48] F. Johnson,et al. ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety. , 2010, The journal of pain : official journal of the American Pain Society.
[49] R. Treede,et al. Recommendations for the Pharmacological Management of Neuropathic Pain: An Overview and Literature Update SUPPLEMENT ARTICLE , 2010 .
[50] Nathaniel Katz. Enriched Enrollment Randomized Withdrawal Trial Designs of Analgesics: Focus on Methodology , 2009, The Clinical journal of pain.
[51] D. Tu,et al. Nortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trial , 2009, The Lancet.
[52] J. Markenson,et al. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. , 2009, Osteoarthritis and cartilage.
[53] Donald A. Berry,et al. Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development , 2009 .
[54] J. Lee,et al. Dose Escalation Methods in Phase I Cancer Clinical Trials , 2009, Journal of the National Cancer Institute.
[55] Ian Harvey,et al. A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers , 2009, Canadian Medical Association Journal.
[56] Michael A Proschan,et al. Sample size re‐estimation in clinical trials , 2009, Biometrical journal. Biometrische Zeitschrift.
[57] F. Vaida,et al. Smoked Medicinal Cannabis for Neuropathic Pain in HIV: A Randomized, Crossover Clinical Trial , 2009, Neuropsychopharmacology.
[58] T. Ho,et al. Efficient assessment of neuropathic pain drugs in patients with small fiber sensory neuropathies , 2009, PAIN®.
[59] H. Kraemer,et al. The history and current state of antidepressant clinical trial design: a call to action for proof-of-concept studies. , 2008, The Journal of clinical psychiatry.
[60] M. Rowbotham,et al. Placebo response in neuropathic pain trials , 2008, PAIN.
[61] S. Straube,et al. Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain. A systematic review. , 2008, British journal of clinical pharmacology.
[62] Christopher L. Wu,et al. Morphine versus Mexiletine for Treatment of Postamputation Pain: A Randomized, Placebo-controlled, Crossover Trial , 2008, Anesthesiology.
[63] L. Lasagna,et al. Do "placebo responders" exist? , 2008, Contemporary clinical trials.
[64] D. Price,et al. Long-term trials of pregabalin and duloxetine for fibromyalgia symptoms: How study designs can affect placebo factors , 2008, PAIN.
[65] S. Fishman,et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. , 2008, The journal of pain : official journal of the American Pain Society.
[66] Anastasia Ivanova,et al. Adaptive dose finding based on t‐statistic for dose–response trials , 2008, Statistics in medicine.
[67] Shein-Chung Chow,et al. Adaptive design methods in clinical trials – a review , 2008, Orphanet journal of rare diseases.
[68] R. Jamison,et al. Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. , 2008, The journal of pain : official journal of the American Pain Society.
[69] R. Moore,et al. Enriched enrolment with randomised withdrawal (EERW): Time for a new look at clinical trial design in chronic pain , 2008, PAIN.
[70] E Jenny Heathcote,et al. Orphanet Journal of Rare BioMed Central Review Primary biliary cirrhosis , 2008 .
[71] R. Dworkin,et al. Clinical trial outcome in neuropathic pain , 2008, Neurology.
[72] K Longley,et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome , 2007, Annals of the rheumatic diseases.
[73] V. Yu,et al. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. , 2008, The journal of pain : official journal of the American Pain Society.
[74] J. Farrar,et al. Pharmacologic management of neuropathic pain: Evidence-based recommendations , 2007, PAIN.
[75] M. Krams,et al. Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials , 2007, Journal of biopharmaceutical statistics.
[76] P. Shekelle,et al. Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society , 2007, Annals of Internal Medicine.
[77] Xiaohong Huang,et al. An examination of the efficiency of the sequential parallel design in psychiatric clinical trials , 2007, Clinical trials.
[78] W Ewy,et al. Model‐based Drug Development , 2007, Clinical pharmacology and therapeutics.
[79] M. Max,et al. Morphine, nortriptyline and their combination vs. placebo in patients with chronic lumbar root pain , 2007, PAIN.
[80] Geert Molenberghs,et al. Missing Data in Clinical Studies , 2007 .
[81] D. Rubin,et al. Diagnostics for confounding in PK/PD models for oxcarbazepine , 2007, Statistics in medicine.
[82] Yoshiaki Matsumoto,et al. Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain. , 2007, Biological & pharmaceutical bulletin.
[83] Sarah Zohar,et al. Optimal designs for estimating the most successful dose , 2006, Statistics in medicine.
[84] Vladimir Dragalin,et al. Adaptive Designs: Terminology and Classification , 2006 .
[85] T. Nurmikko,et al. EFNS guidelines on pharmacological treatment of neuropathic pain , 2006, European journal of neurology.
[86] C. Schmid,et al. Lessons learned combining N-of-1 trials to assess fibromyalgia therapies. , 2006, The Journal of rheumatology.
[87] M. Krams,et al. Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group , 2006, Journal of biopharmaceutical statistics.
[88] G. Levy,et al. A two-stage design for a phase II clinical trial of coenzyme Q10 in ALS , 2006, Neurology.
[89] H. Sievers,et al. Efficacy and tolerability of a spray with Salvia officinalis in the treatment of acute pharyngitis - a randomised, double-blind, placebo-controlled study with adaptive design and interim analysis. , 2006, European journal of medical research.
[90] Andrew P Grieve,et al. Implementation of a Bayesian adaptive design in a proof of concept study , 2006, Pharmaceutical statistics.
[91] D. Berry. Bayesian clinical trials , 2006, Nature Reviews Drug Discovery.
[92] Nathaniel Katz. Methodological issues in clinical trials of opioids for chronic pain , 2005, Neurology.
[93] M. Max,et al. Topiramate in chronic lumbar radicular pain. , 2005, The journal of pain : official journal of the American Pain Society.
[94] D. Tu,et al. Morphine, gabapentin, or their combination for neuropathic pain. , 2005, The New England journal of medicine.
[95] J. Farrar,et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations , 2003, Pain.
[96] J. Stoner. Cross-over Trials in Clinical Research , 2004 .
[97] D. Moher,et al. Turning a blind eye:Testing the success of blinding and the CONSORT statement , 2004, BMJ : British Medical Journal.
[98] D. Sackett. Turning a blind eye:Why we don't test for blindness at the end of our trials , 2004, BMJ : British Medical Journal.
[99] S. Senn. Turning a blind eye: Authors have blinkered view of blinding , 2004, BMJ : British Medical Journal.
[100] Jack A. Cook,et al. The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain , 2003, Pharmaceutical Research.
[101] David A. Schoenfeld,et al. The Problem of the Placebo Response in Clinical Trials for Psychiatric Disorders: Culprits, Possible Remedies, and a Novel Study Design Approach , 2003, Psychotherapy and Psychosomatics.
[102] Christopher Jennison,et al. Mid‐course sample size modification in clinical trials based on the observed treatment effect , 2002, Statistics in medicine.
[103] T. Travison,et al. Opioids versus antidepressants in postherpetic neuralgia: A randomized, placebo-controlled trial , 2002, Neurology.
[104] M. Jensen,et al. Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial , 2002, PAIN.
[105] M. Max,et al. Dextromethorphan and Memantine in Painful Diabetic Neuropathy and Postherpetic Neuralgia: Efficacy and Dose-Response Trials , 2002, Anesthesiology.
[106] Christopher L. Wu,et al. Analgesic Effects of Intravenous Lidocaine and Morphine on Postamputation Pain: A Randomized Double-blind, Active placebo-controlled, Crossover Trial , 2002, Anesthesiology.
[107] T. Yaksh,et al. Concentration–effect relationship of intravenous alfentanil and ketamine on peripheral neurosensory thresholds, allodynia and hyperalgesia of neuropathic pain , 2001, Pain.
[108] M. Max,et al. A randomized, controlled trial of high-dose dextromethorphan in facial neuralgias , 2000, Neurology.
[109] T. Yaksh,et al. Concentration–Effect Relationship of Intravenous Lidocaine on the Allodynia of Complex Regional Pain Syndrome Types I and II , 2000, Anesthesiology.
[110] C. S. Davis,et al. Threats to the validity of clinical trials employing enrichment strategies for sample selection. , 1998, Controlled clinical trials.
[111] Adrian Dunne,et al. Analysis of Nonrandomly Censored Ordered Categorical Longitudinal Data from Analgesic Trials , 1997 .
[112] Stephen Senn,et al. Statistical Issues in Drug Development , 1997 .
[113] M. Max,et al. High‐dose oral dextromethorphan versus placebo in painful diabetic neuropathy and postherpetic neuralgia , 1997, Neurology.
[114] J. Vanneste,et al. Randomised double-blind active-placebo-controlled crossover trial of intravenous fentanyl in neuropathic pain , 1997, The Lancet.
[115] M. Rowbotham,et al. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia , 1996, Pain.
[116] M. Byas-Smith,et al. Transdermal clonidine compared to placebo in painful diabetic neuropathy using a two-stage ‘enriched enrollment’ design , 1995, Pain.
[117] L B Sheiner,et al. A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data , 1994, Clinical pharmacology and therapeutics.
[118] Jon Smith. Crossover Trials in Clinical Research: By Stephen Senn. John Wiley & Sons Ltd., 1993. pp. xv + 266. £24.95. ISBN 0-471-93493-3 , 1993 .
[119] Stephen Senn,et al. Cross-over trials in clinical research , 1993 .
[120] K. Schechtman,et al. A comprehensive algorithm for determining whether a run-in strategy will be a cost-effective design modification in a randomized clinical trial. , 1993, Statistics in medicine.
[121] J. Matthews,et al. Serial correlation in the design and analysis of crossover trials , 1991 .
[122] M. Rowbotham,et al. Both intravenous lidocaine and morphine reduce the pain of postherpetic neuralgia , 1991, Neurology.
[123] Klein Df. Improvement of phase III psychotropic drug trials by intensive phase II work. , 1991 .
[124] R M Bennett,et al. The fibromyalgia impact questionnaire: development and validation. , 1991, The Journal of rheumatology.
[125] D. Klein. Improvement of phase III psychotropic drug trials by intensive phase II work. , 1991, Neuropsychopharmacology.
[126] J. Wittes,et al. The run-in period in clinical trials. The effect of misclassification on efficiency. , 1990, Controlled clinical trials.
[127] K. Brøsen,et al. The selective serotonin reuptake inhibitor paroxetine is effective in the treatment of diabetic neuropathy symptoms , 1990, Pain.
[128] M. Kenward,et al. Design and Analysis of Cross-Over Trials , 1989 .
[129] R. Dubner,et al. Amitriptyline, but not lorazepam, relieves postherpetic neuralgia , 1988, Neurology.
[130] R. Dubner,et al. Association of pain relief with drug side effects in postherpetic neuralgia: A single‐dose study of clonidine, codeine, ibuprofen, and placebo , 1988, Clinical pharmacology and therapeutics.
[131] R. Dubner,et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood , 1987, Neurology.
[132] R. Dubner,et al. Suppression of postoperative pain by the combination of a nonsteroidal anti-inflammatory drug, flurbiprofen, and a long-acting local anesthetic, etidocaine. , 1984, Journal of the American Dental Association.
[133] P. Fox,et al. Comparison of conorphone, a mixed agonist-antagonist analgesic, to codeine for postoperative dental pain. , 1984, Anesthesia progress.
[134] David S. H. Bell. Amitriptyline versus placebo in postherpetic neuralgia , 1983, Neurology.
[135] H. Merskey,et al. Amitriptyline versus placebo in post-herpetic neuralgia , 1981, PAIN.
[136] J. Lellouch,et al. EXPLANATORY AND PRAGMATIC ATTITUDES IN THERAPEUTICAL TRIALS , 2003 .
[137] E. Laska,et al. Oral analgesic studies: Pentazocine hydrochloride, codeine, aspirin, and placebo and their influence on response to placebo , 1966, Clinical pharmacology and therapeutics.