Calendario›CGC›Canadian Registry for the Use of Spectrum Therapeutics Cannabis Products in Subjects With Chronic Pain
Canadian Registry for the Use of Spectrum Therapeutics Cannabis Products in Subjects With Chronic Pain
Ensayo de Canopy Growth Corp en Chronic Pain (del registro, en inglés).
- Fase
- no aplica
- Estado
- Sin noticias del promotor
- Participantes
- 500
- Centros
- 1
- Fin del objetivo primario
- jul 2023
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en ene 2021.
Qué mide
Physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen and changes over time (Collected at each physician-verified visit (5) over the course of 1-year.) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroChronic pain affects at least 10% of the global population but is often poorly managed, given the variable efficacy of available pharmacological treatments and the limited accessibility of multidisciplinary interventions. The legalization of cannabis in at least 14 countries and the increasing regulatory approval of cannabis preparations and synthetic cannabinoids and analogues have led to a growing interest in the use of medical cannabis products to manage chronic pain. This use is supported by research demonstrating important interactions between cannabinoids and the human endocannabinoid system and pain modulation pathways. While medical cannabis products are increasingly available to practitioners who treat pain, there is little evidence-based guidance for prescribing or titrating these treatments to manage chronic non-cancer pain. This prospective registry aims to assemble real-world data regarding the use of Spectrum Therapeutics (ST) medical cannabis products in subjects with chronic non-cancer pain in Canada. The registry will also assess treatment outcomes, including pain and related symptoms, global impressions of improvement, and change in concomitant pain medications (opioid use in particular), to better inform the utility of ST products for chronic non-cancer pain management. Primary Objective: • To describe patterns of physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen, expressed as average daily dose of THC and CBD (in mg), and mode of administration (ingested or inhaled), in the management of chronic non-cancer pain in countries where these products are commercially available. Secondary Objectives: * To describe subject product and dose adjustment (under medical follow-up) over time. * To assess outcomes of treatment, including pain relief and effects on sleep, daily functioning, and quality of life. * To assess global impressions of treatment effectiveness as reported by subjects and physicians. * To assess changes in daily dose of opioids, other medications over time. Safety Objective: • To assess the safety and tolerability of ST products in subjects with chronic pain.
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Todos los de CGC, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04763252), actualizada en ago 2022.