WHO ICTRP trial

Randomized, double blind, parallel groups, placebo controlled pivotal clinical…

EUCTR2004-003824-36-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2004-003824-36-ES
Public title Randomized, double blind, parallel groups, placebo controlled pivotal clinical trial to asses preliminary efficacy and security of a sublingual Cannabis Standardized Extract (Sativex) added to reference treatment for prevention and treatment of nausea and late vomiting induced by moderately emetogenic chemotherapy. - SATEME-08
Scientific title Randomized, double blind, parallel groups, placebo controlled pivotal clinical trial to asses preliminary efficacy and security of a sublingual Cannabis Standardized Extract (Sativex) added to reference treatment for prevention and treatment of nausea and late vomiting induced by moderately…
Primary sponsor Fundació Institut Català de Farmacologia
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Countries Spain
Conditions Chemotherapy induced nausea and vomiting
Interventions Trade Name: Sativex Product Name: delta9 tetrahidrocannabinol (THC) y cannabidiol (CBD) Product Code: THC CBD Pharmaceutical Form: Sublingual spray INN or Proposed INN: Delta-9-Tetrahidrocannabinol (THC) Concentration unit: mg/ml…
Registration date May 9, 2005
Secondary IDs SATEME-08
Registry page clinicaltrialsregister.eu

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