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

Completed · Phase 2

Conditions studied: Palliative Care, Pain, Cancer

In brief

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.

Key facts

Study ID

NCT00530764

Run by

GW Pharmaceuticals Ltd

People needed

360

Starts

2007-11-01

Expected to finish

2010-01-01

Last updated by the study team

2013-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• The Center for Clinical Research - Washington County Hospital — Hagerstown, Maryland, United States
• Capital Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• A & A Pain Institute of St. Louis — St Louis, Missouri, United States
• Office of Donald H. Berdeaux MD — Great Falls, Montana, United States
• Summit Medical Group — Berkeley Heights, New Jersey, United States
• Beth Israel Medical Center — New York, New York, United States
• Metropolitan Hospital Center — New York, New York, United States
• Four Seasons Hospice & Pallative Care — Flat Rock, North Carolina, United States
• Center for Clinical Research — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Lone Star Oncology — Austin, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Jules Bordet Institute — Brussels, Belgium
• CHU Charleroi (Hôpital civil de Charleroi) — Charleroi, Belgium
• Cancer Care Center of Tuscaloosa — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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