CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 360 enrolled
Drug / intervention
Sativex Low Dose +2 moredrug
Likely dose
Sativex Low Dose 2.7mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00530764
NCT00530764Phase 2Completed
CompareCT.gov

A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

GW Pharmaceuticals Ltd·interventional·Posted Sep 17, 2007·Updated Jun 20, 2013

In Brief

A Phase 2 clinical trial evaluating Sativex Low Dose, Sativex Medium Dose, and 1 other intervention for Palliative Care and 2 related conditions. Completed, enrolled 360 participants across 110 sites in 16 countries.

Detailed Summary

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPalliative Care, Pain, Cancer
CountriesBelgium, Canada, Chile, Czechia, Finland, France, Germany, India, Italy, Mexico, Poland, Romania, South Africa, Spain, United Kingdom, United States
CollaboratorsQuintiles, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 17, 2007
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.8 years ago

Interventions

Sativex Low Dosedrug

Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.

Sativex Medium Dosedrug

Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.

Sativex High Dosedrug

Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.