A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.
NCT ID: NCT00530764
Last Updated: 2013-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2007-11-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Sativex Low Dose
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 Low Dose
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 Dose
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 Medium Dose
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 Dose
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.
Sativex High Dose
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.
Placebo
Range of 1-16 sprays per day of placebo spray.
No interventions assigned to this group
Interventions
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Sativex Low Dose
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 Dose
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 Dose
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
GW Pharmaceuticals Ltd
INDUSTRY
Responsible Party
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Locations
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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
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
UZ Leuven - Algologisch Centrum Anesthesiologie
Pellenberg, , Belgium
Vancouver Health Research Center
Victoria, British Columbia, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Instituto Radio-oncológico Santiago (INRAD)
Santiago, , Chile
Clínica Ciudad del Mar
Viña del Mar, , Chile
Ambulance pro lécbu bolesti, ARO
Benešov, , Czechia
Ambulance pro lécbu bolesti
České Budějovice, , Czechia
Nemocnice Ceské Budejovice
České Budějovice, , Czechia
FN Hradec Králové - Klinika onkologie a radioterapie
Hradec Králové, , Czechia
Nemocnice Jihlava
Jihlava, , Czechia
FN a LF UP Olomouc - Ambulance pro lécbu bolesti
Olomouc, , Czechia
AR klinika FN Plzen -Ambulance pro lécbu bolesti
Pilsen, , Czechia
Fakultní nemocnice Na Bulovce
Praha 8 - Liben, , Czechia
ARO, Krajská zdravotni, K.Z. a.s, Nemocnice
Teplice, , Czechia
Docrates Clinic
Helsinki, , Finland
Centre hospitalier Lyon Sud
Pierre-Bénite, , France
Praticien hospitalier
Tarbes, , France
RWTH Aachen Universität
Aachen, , Germany
Schmerz- und Palliativzentrum Göppingen
Göppingen, , Germany
St.-Marien-Hospital Lunen
Lünen, , Germany
Schmeiz - u Pallielivzendium Wiesbaden
Wiesbaden, , Germany
Yashoda Hospital
Andhra Pradesh, , India
Bangalore Institute of Oncology
Bangalore, , India
CBCC- Apollo Hospital
Gandhinagar, , India
Apollo Hospital
Hyderabaad, , India
Indo-American Cancer Institute and Research Center
Hyderabaad, , India
Bhagwaan Mahaveer Cancer Hospital and Research Centre
Jaipur, , India
CHL - Apollo Hospitals
Madhya Pradesh, , India
Jawaharlal Nehru Cancer Hospital
Madhya Pradesh, , India
Meenakshi Mission Hospital & Research Centre
Madurai, , India
All India Institute of Medical Sciences
New Delhi, , India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, , India
Deenanath Mangeshkar Hospital and Research Center
Pune, , India
Seroc Cancer Center
Rajasthan, , India
Regina Elana Cancer Institute
Rome, , Italy
Dir. S.C.D.U. Psicologia Clinica ed Oncologica
Turin, , Italy
Hospital Aranda de la Parra
León, , Mexico
Htal Ángeles de Pedregal
Mexico City, , Mexico
Beskidzkie Centrum Onkologii im. Jana Pawla
Bielsko-Biala, , Poland
Poradnia Leczenia Bolu
Edyty Jakubow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Gdansk, , Poland
NZOZ Hospicjum Milosierdzia Bozego
Gliwice, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Wielkopolskie Centrum Onkologii
Poznan, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Tychy, , Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie
Warsaw, , Poland
Spitalul Judetean de Urgenta "Constantin Opris"
Baia Mare, Maramures, , Romania
Spitalul Judetean de Urgenta Braila
Braila, Jud. Braila, , Romania
Hospice "Casa Sperantei"
Brasov, , Romania
Spitalul Universitar de Urgenta Elias
Bucharest, , Romania
S.C. IanuliMed S.R.L. Oncologie Medicala
Bucharest, , Romania
Policnica Orizont-Oncologie Medicala
Craiova, , Romania
District Hospital Dr. Alexandru Simionescu
Hunedoara, , Romania
Centrul de Oncologie Medicala
Iași, , Romania
Spitalul Municipal Onesti
Onesti, Jud. Bacau, , Romania
Spitalul Municipal Ploiesti
Ploieşti, , Romania
Spitalul Clinic Judetean Sibiu Oncologie
Sibiu, , Romania
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"
Suceava, , Romania
Medi Clinic
Bloemfontein, , South Africa
Pain Clinic
Cape Town, , South Africa
Dr. Pirjol & Szpak Inc.
eManzimtoti, , South Africa
Pretoria Urology Research Unit
Hatfield, Pretoria, , South Africa
Trialtech Research - Embassy Drive Medical Centre
Hatfield, Pretoria, , South Africa
Oncology/Haematology Dept Research Unit
Kimberley, , South Africa
Eastleigh Breast Cancer Center
Lynnwood, , South Africa
Hospital Virgen del Mar
Almería, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
HU Puerta del Mar, Oncologia
Cadiz, , Spain
Hospital Universitario de Bellvitge
Feixa, Llarga, Sn, , Spain
Hospital Univ. Virgen de las Nieves
Granada, , Spain
Hospital de la Rioja
Logroño, , Spain
Hospital Los Montalvos
Salamanca, , Spain
Basingstoke & North Hampshire NHS Foundation Trust
Basingstoke, , United Kingdom
West Suffolk Hospital
Bury St Edmunds, , United Kingdom
Fairfield General Hospital
Bury, Lancashire, , United Kingdom
Edinburgh Cancer Research Centre (CRUK)
Edinburgh, , United Kingdom
James Paget Hospital
Gorleston on Sea, Norfolk, , United Kingdom
International Observatory on End of Life Care
Lancaster, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Marie Curie Hospice Holme Tower
Penarth, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Weston Area Health Trust
Weston-super-Mare, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.
Other Identifiers
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GWCA0701
Identifier Type: -
Identifier Source: org_study_id
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