SPRAY (A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy)
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Estudio primario

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Un Estudio de Sativex® para el alivio del dolor en pacientes con neoplasias malignas avanzadas

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Registro de estudios clinicaltrials.gov
Año 2002
Enlaces Registro de estudios

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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El propósito de este estudio es determinar si Sativex® y GW-2000-02 son eficaces en la gestión de los sujetos con dolor relacionado con el cáncer intratable.

Estudio primario

No clasificado

Un Estudio de Sativex® para el alivio del dolor en pacientes con neoplasias malignas avanzadas.

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Autores GWPharm
Registro de estudios clinicaltrials.gov
Año 2007
Enlaces Registro de estudios

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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El propósito de este estudio es determinar el rango de dosis efectiva y demostrar una rango de dosis no efectiva de Sativex en pacientes con cáncer avanzado, que experimentan alivio del dolor inadecuada a pesar de que están en tratamiento crónico con opioides optimizado.

Estudio primario

No clasificado

Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial.

Revista The journal of pain : official journal of the American Pain Society
Año 2012
Enlaces Pubmed DOI

Este artículo está incluido en 30 Revisiones sistemáticas Revisiones sistemáticas (30 referencias) 3 Síntesis amplias Síntesis amplias (3 referencias)

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UNLABELLED: Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge. Nabiximols (Nabiximols is the U.S. Adopted Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, U.K.], which does not yet have an INN), a novel cannabinoid formulation, is undergoing investigation as add-on therapy for this population. In a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1-4 sprays/day), medium dose (6-10 sprays/day), or high dose (11-16 sprays/day). Average pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment; other questionnaires measured quality of life and mood. A total of 360 patients were randomized; 263 completed. There were no baseline differences across groups. The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain (P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events were dose-related and only the high-dose group compared unfavorably with placebo. This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials. PERSPECTIVE: Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for patients with opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled, graded-dose study demonstrated efficacy and safety at low and medium doses.