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

PHASE2CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
Palliative CarePainCancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (110)

1000

Jules Bordet Institute, Brussels

3212

UZ Leuven - Algologisch Centrum Anesthesiologie, Pellenberg

4126

Dr. Pirjol & Szpak Inc., eManzimtoti

6000

CHU Charleroi (Hôpital civil de Charleroi), Charleroi

8001

Pain Clinic, Cape Town

8301

Oncology/Haematology Dept Research Unit, Kimberley

9301

Medi Clinic, Bloemfontein

10003

Beth Israel Medical Center, New York

10029

Metropolitan Hospital Center, New York

10128

Dir. S.C.D.U. Psicologia Clinica ed Oncologica, Turin

10700

Htal Ángeles de Pedregal, Mexico City

11009

HU Puerta del Mar, Oncologia, Cadiz

21740

The Center for Clinical Research - Washington County Hospital, Hagerstown

25601

Ambulance pro lécbu bolesti, ARO, Benešov

26001

Hospital de la Rioja, Logroño

27103

Center for Clinical Research, Winston-Salem

28731

Four Seasons Hospice & Pallative Care, Flat Rock

30274

Center of Hope for Cancer and Blood Disorders, Riverdale

32257

Florida Institute of Medical Research, Jacksonville

33617

Clinical Pharmacology Services, Tampa

35406

Cancer Care Center of Tuscaloosa, Tuscaloosa

37000

Hospital Aranda de la Parra, León

37192

Hospital Los Montalvos, Salamanca

37232

Vanderbilt-Ingram Cancer Center, Nashville

41501

ARO, Krajská zdravotni, K.Z. a.s, Nemocnice, Teplice

44534

St.-Marien-Hospital Lunen, Lünen

44718

Gabrail Cancer Center, Canton

52074

RWTH Aachen Universität, Aachen

58633

Nemocnice Jihlava, Jihlava

59405

Office of Donald H. Berdeaux MD, Great Falls

63141

A & A Pain Institute of St. Louis, St Louis

65000

Praticien hospitalier, Tarbes

65109

Capital Comprehensive Cancer Care Clinic, Jefferson City

65189

Schmeiz - u Pallielivzendium Wiesbaden, Wiesbaden

69495

Centre hospitalier Lyon Sud, Pierre-Bénite

70114

Louisiana Research Associates, New Orleans

73033

Schmerz- und Palliativzentrum Göppingen, Göppingen

78759

Lone Star Oncology, Austin

84112

Huntsman Cancer Institute, Salt Lake City

85222

Desert Oasis Cancer Center, Casa Grande

92037

University of California San Diego, La Jolla

92354

Loma Linda University, Loma Linda

92708

Pacific Coast Hematology/Oncology Medical Group, Inc., Fountain Valley

95020

Office of Dr. Ronald Yanagihara, Gilroy

100337

Spitalul Municipal Ploiesti, Ploieşti

180114

Hospital Univ. Virgen de las Nieves, Granada

200535

Policnica Orizont-Oncologie Medicala, Craiova

302017

Bhagwaan Mahaveer Cancer Hospital and Research Centre, Jaipur

331057

District Hospital Dr. Alexandru Simionescu, Hunedoara

411001

Jehangir Clinical Development Centre Pvt. Ltd., Pune

430031

"Spitalul Judetean de Urgenta Constantin Opris", Baia Mare, Maramures

500033

Apollo Hospital, Hyderabaad

500034

Indo-American Cancer Institute and Research Center, Hyderabaad

500074

"Hospice Casa Sperantei", Brasov

550245

Spitalul Clinic Judetean Sibiu Oncologie, Sibiu

560027

Bangalore Institute of Oncology, Bangalore

601048

Spitalul Municipal Onesti, Onesti, Jud. Bacau

625107

Meenakshi Mission Hospital & Research Centre, Madurai

700106

Centrul de Oncologie Medicala, Iași

720237

"Spitalul Judetean de Urgenta Sf. Ioan cel Nou", Suceava

810325

Spitalul Judetean de Urgenta Braila, Braila, Jud. Braila

07922

Summit Medical Group, Berkeley Heights

V8V 1R2

Vancouver Health Research Center, Victoria

H3T 1E2

Jewish General Hospital, Montreal

Unknown

Instituto Radio-oncológico Santiago (INRAD), Santiago

Clínica Ciudad del Mar, Viña del Mar

CBCC- Apollo Hospital, Gandhinagar

Deenanath Mangeshkar Hospital and Research Center, Pune

Poradnia Leczenia Bolu, Edyty Jakubow

370 01

Ambulance pro lécbu bolesti, České Budějovice

370 87

Nemocnice Ceské Budejovice, České Budějovice

500 05

FN Hradec Králové - Klinika onkologie a radioterapie, Hradec Králové

775 20

FN a LF UP Olomouc - Ambulance pro lécbu bolesti, Olomouc

304 60

AR klinika FN Plzen -Ambulance pro lécbu bolesti, Pilsen

180 81

Fakultní nemocnice Na Bulovce, Praha 8 - Liben

00150

Docrates Clinic, Helsinki

500 082

Yashoda Hospital, Andhra Pradesh

452 008

CHL - Apollo Hospitals, Madhya Pradesh

462 001

Jawaharlal Nehru Cancer Hospital, Madhya Pradesh

110 029

All India Institute of Medical Sciences, New Delhi

302 013

Seroc Cancer Center, Rajasthan

00144

Regina Elana Cancer Institute, Rome

43-300

Beskidzkie Centrum Onkologii im. Jana Pawla, Bielsko-Biala

80-803

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Gdansk

44-101

NZOZ Hospicjum Milosierdzia Bozego, Gliwice

31-631

Szpital Uniwersytecki w Krakowie, Krakow

61-866

Wielkopolskie Centrum Onkologii, Poznan

43-100

Niepubliczny Zaklad Opieki Zdrowotnej, Tychy

02-781

Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Warsaw

011461

Spitalul Universitar de Urgenta Elias, Bucharest

020962

S.C. IanuliMed S.R.L. Oncologie Medicala, Bucharest

0083

Pretoria Urology Research Unit, Hatfield, Pretoria

Trialtech Research - Embassy Drive Medical Centre, Hatfield, Pretoria

0041

Eastleigh Breast Cancer Center, Lynnwood

04003

Hospital Virgen del Mar, Almería

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

08907

Hospital Universitario de Bellvitge, Feixa, Llarga, Sn

RG24 9NA

Basingstoke & North Hampshire NHS Foundation Trust, Basingstoke

IP33 2QZ

West Suffolk Hospital, Bury St Edmunds

BL9 7TD

Fairfield General Hospital, Bury, Lancashire

EH4 2XR

Edinburgh Cancer Research Centre (CRUK), Edinburgh

NR31 6LA

James Paget Hospital, Gorleston on Sea, Norfolk

LA1 4YT

International Observatory on End of Life Care, Lancaster

EC1A 7BE

St Bartholomew's Hospital, London

SW3 6LL

The Royal Marsden NHS Foundation Trust, London

CF64 3YR

Marie Curie Hospice Holme Tower, Penarth

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

BS23 4TQ

Weston Area Health Trust, Weston-super-Mare

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors
All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

GW Pharmaceuticals Ltd

INDUSTRY