Tetrodotoxin for Moderate to Severe Cancer-Related Pain: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Trial
| العنوان: | Tetrodotoxin for Moderate to Severe Cancer-Related Pain: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Trial |
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| المؤلفون: | Bernard Lapointe, Patrick du Souich, John Constant, May Ong-Lam, Lyne Cantin, Tina Haller, Walter Korz, Neil A. Hagen, Gilbert Blaise |
| المصدر: | Pain Research & Management Pain Research and Management, Vol 2017 (2017) |
| بيانات النشر: | Hindawi Limited, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Adult, Male, Article Subject, Nausea, Injections, Subcutaneous, Analgesic, Population, Tetrodotoxin, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Quality of life, Randomized controlled trial, law, medicine, Humans, Anesthetics, Local, education, Adverse effect, Aged, lcsh:R5-920, education.field_of_study, business.industry, Cancer Pain, Middle Aged, Treatment Outcome, Anesthesiology and Pain Medicine, Neurology, 030220 oncology & carcinogenesis, Anesthesia, Clinical Study, Female, medicine.symptom, lcsh:Medicine (General), Cancer pain, business, 030217 neurology & neurosurgery |
| الوصف: | Objective. This study evaluated subcutaneous injections of tetrodotoxin (TTX) for the treatment of moderate to severe, inadequately controlled cancer-related pain.Methods. Eligible patients were randomized to receive TTX (30 μg) or placebo subcutaneously twice daily for four consecutive days. Efficacy was assessed using pain and composite endpoints (including pain and quality of life measures), and safety was evaluated using standard measures.Results. 165 patients were enrolled at 19 sites in Canada, Australia, and New Zealand, with 149 patients in the primary analysis “intent-to-treat” population. The primary analysis supports a clinical benefit of TTX over placebo based on the pain endpoint alone with a clinically significant estimated effect size of 16.2% (p=0.0460). Thepvalue was nominally statistically significant after prespecified (Bonferroni Holm) adjustment for the two primary endpoints but not at the prespecified two-sided 5% level. The mean duration of analgesic response was 56.7 days (TTX) and 9.9 days (placebo). Most common adverse events were nausea, dizziness, and oral numbness or tingling and were generally mild to moderate and transient.Conclusions. Although underpowered, this study demonstrates a clinically important analgesic signal. TTX may provide clinically meaningful analgesia for patients who have persistent moderate to severe cancer pain despite best analgesic care. This clinical study is registered with ClinicalTrials.gov (NCT00725114). |
| وصف الملف: | text/xhtml |
| تدمد: | 1918-1523 1203-6765 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51e2ded313734a318f432252c2414d63 https://doi.org/10.1155/2017/7212713 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....51e2ded313734a318f432252c2414d63 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19181523 12036765 |
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