Predicting therapeutic efficacy — Experimental pain in human subjects

Chizh, Boris A.; Priestley, Tony; Rowbotham, Michael C.; Schaffler, K.

doi:10.1016/j.brainresrev.2008.12.016

Cited by 53 publications

(69 citation statements)

References 47 publications

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“…However to increase the validity of the findings in experimental pain the finding of doseresponse curves with significant slopes supports the idea of an analgesic effect that could be translatable into clinical pain [8,125].…”

Section: Figurementioning

confidence: 61%

Assessing analgesic actions of opioids by experimental pain models in healthy volunteers – an updated review

Staahl

Olesen

Andresen

et al. 2009

Brit J Clinical Pharma

113

131

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AIMExperimental pain models may help to evaluate the mechanisms of action of analgesics and target the clinical indications for their use. This review addresses how the efficacy of opioids can be assessed in human volunteers using experimental pain models. The drawback with the different study designs is also discussed. METHODA literature search was completed for randomized controlled studies which included human experimental pain models, healthy volunteers and opioids. RESULTSOpioids with a strong affinity for the m-opioid receptor decreased the sensation in a variety of experimental pain modalities, but strong tonic pain was attenuated more than short lasting pain and non-painful sensations. The effects of opioids with weaker affinity for the m-opioid receptor were detected by a more narrow range of pain models, and the assessment methods needed to be more sensitive. CONCLUSIONThe way the pain is induced, assessed and summarized is very important for the sensitivity of the pain models. This review gives an overview of how different opioids perform in experimental pain models. Generally experimental pain models need to be designed with careful consideration of pharmacological mechanisms and pharmacokinetics of analgesics. This knowledge can aid the decisions needed to be taken when designing experimental pain studies for compounds entering phase 1 clinical trials.

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Section: Figurementioning

confidence: 61%

Assessing analgesic actions of opioids by experimental pain models in healthy volunteers – an updated review

Staahl

Olesen

Andresen

et al. 2009

Brit J Clinical Pharma

113

131

View full text Add to dashboard Cite

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“…Of these, only one new target has been discovered: the gabapentinoids (Chizh et al, 2009). There could be several reasons for this lack of success in drug development, but one of the explanations could be that the preclinical pain models do not properly predict the clinical efficacy in humans (Kola and Landis, 2004;Chizh et al, 2009). …”

Section: Animal Versus Human Pain Modelsmentioning

confidence: 99%

“…Hence, in animals, there is an under-representation of key brain areas dealing with the affective component of pain (Price, 2000(Price, , 2002. Finally, because many of these models are also optimized for success, the construct validity is often limited (Chizh et al, 2009); in fact, only one analgesic (ziconotide) has ever gone from bench to bedside on the basis of animal models alone (Dolgin, 2010).…”

Section: Animal Versus Human Pain Modelsmentioning

confidence: 99%

Human Experimental Pain Models for Assessing the Therapeutic Efficacy of Analgesic Drugs

et al. 2012

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“…In their study, the authors noted a positive treatment effect during placebo trials which, interestingly, disappeared progressively following repeat exposures to placebos 11,12 . Sadly treatments over time, as described in Table 1.…”

Section: Decaying Treatment Effects May Be the Solutionmentioning

confidence: 91%

Randomized placebo-controlled cross-over designs in clinical trials: a gold standard to be reassessed

Léonard

Lafrenaye

Goffaux

2012

Current Medical Research and Opinion

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Predicting therapeutic efficacy — Experimental pain in human subjects

Cited by 53 publications

References 47 publications

Assessing analgesic actions of opioids by experimental pain models in healthy volunteers – an updated review

Assessing analgesic actions of opioids by experimental pain models in healthy volunteers – an updated review

Human Experimental Pain Models for Assessing the Therapeutic Efficacy of Analgesic Drugs

Randomized placebo-controlled cross-over designs in clinical trials: a gold standard to be reassessed

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