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COMPLETEDPHASE2

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.

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.

NCT00530764•GW Pharmaceuticals Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient has advanced active cancer for which there is no known curative therapy.
•The patient is able (in the investigators opinion) and willing to comply with all study requirements.
•The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
•The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder.
•The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.

Exclusion Criteria

•The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
•Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
•Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
•The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
•The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.

Locations (110)

Cancer Care Center of Tuscaloosa

Tuscaloosa, Alabama, United States

Desert Oasis Cancer Center

Casa Grande, Arizona, United States

Pacific Coast Hematology/Oncology Medical Group, Inc.

Fountain Valley, California, United States

Office of Dr. Ronald Yanagihara

Gilroy, California, United States

University of California San Diego

La Jolla, California, United States

Loma Linda University

Loma Linda, California, United States

Florida Institute of Medical Research

Jacksonville, Florida, United States

Clinical Pharmacology Services

Tampa, Florida, United States

Center of Hope for Cancer and Blood Disorders

Riverdale, Georgia, United States

Louisiana Research Associates

New Orleans, Louisiana, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

June 20, 2013

Enrollment

360

ACTUAL participants

Conditions

Palliative CarePainCancer

Interventions

Sativex Low Dose

DRUG

Sativex Medium Dose

DRUG

Sativex High Dose

DRUG

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

NCT07061964

Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8+1 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.

Inclusion Criteria

Exclusion Criteria

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

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Early Detection of Liver Cancer by QUS

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations