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Brief Title: A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.
Official Title: 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.
Study ID: NCT00530764
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Bruxelles, , 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, , Czech Republic
Ambulance pro lécbu bolesti, Ceské Budejovice, , Czech Republic
Nemocnice Ceské Budejovice, Ceské Budejovice, , Czech Republic
FN Hradec Králové - Klinika onkologie a radioterapie, Hradec Králové, , Czech Republic
Nemocnice Jihlava, Jihlava, , Czech Republic
FN a LF UP Olomouc - Ambulance pro lécbu bolesti, Olomouc, , Czech Republic
AR klinika FN Plzen -Ambulance pro lécbu bolesti, Plzen, , Czech Republic
Fakultní nemocnice Na Bulovce, Praha 8 - Liben, , Czech Republic
ARO, Krajská zdravotni, K.Z. a.s, Nemocnice, Teplice, , Czech Republic
Docrates Clinic, Helsinki, , Finland
Centre hospitalier Lyon Sud, Pierre-Benite, , France
Praticien hospitalier, Tarbes, , France
RWTH Aachen Universität, Aachen, , Germany
Schmerz- und Palliativzentrum Göppingen, Göppingen, , Germany
St.-Marien-Hospital Lunen, Lunen, , 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, Rom, , Italy
Dir. S.C.D.U. Psicologia Clinica ed Oncologica, Turin, , Italy
Hospital Aranda de la Parra, Leon, , Mexico
Htal Ángeles de Pedregal, Mexico DF, , 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, Warszawa, , 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, Bucuresti, , Romania
S.C. IanuliMed S.R.L. Oncologie Medicala, Bucuresti, , Romania
Policnica Orizont-Oncologie Medicala, Craiova, , Romania
District Hospital Dr. Alexandru Simionescu, Hunedoara, , Romania
Centrul de Oncologie Medicala, Iasi, , Romania
Spitalul Municipal Onesti, Onesti, Jud. Bacau, , Romania
Spitalul Municipal Ploiesti, Ploiesti, , Romania
Spitalul Clinic Judetean Sibiu Oncologie, Sibiu, , Romania
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou", Suceava, , Romania
Dr. Pirjol & Szpak Inc., Amanzimtoti, , South Africa
Medi Clinic, Bloemfontein, , South Africa
Pain Clinic, Cape Town, , 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, Almeria, , 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, Logrono, , 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