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A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)
This study is ongoing, but not recruiting participants.
First Received: September 13, 2007   Last Updated: October 31, 2009   History of Changes
Sponsor: GW Pharmaceuticals Ltd.
Collaborator: Quintiles
Information provided by: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00530764
  Purpose

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.


Condition Intervention Phase
Palliative Care
Pain
Cancer
Drug: GW-1000-02
Phase II

Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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.

Resource links provided by NLM:


Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain).

Secondary Outcome Measures:
  • Cumulative average pain response curves
  • Mean daily IVRS NRS pain score (average and also worst pain).
  • Brief Pain Inventory - Short Form
  • Sleep Disruption NRS
  • Patient Assessment of Constipation Quality of Life (PAC-QoL)
  • Patient Global Impression of Change - PGIC
  • Montgomery Asberg Depression Rating Scale (MADRS)
  • Addiction Research Center Inventory (ARCI)

Estimated Enrollment: 336
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530764

  Hide Study Locations
Locations
United States, Alabama
Cancer Care Center of Tuscaloosa
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Desert Oasis Cancer Center
Casa Grande, Arizona, United States, 85222
United States, California
Office of Dr. Ronald Yanagihara
Gilroy, California, United States, 95020
University of California San Diego
La Jolla, California, United States, 92037
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States, 92708
Loma Linda University
Loma Linda, California, United States, 92354
United States, Florida
Clinical Pharmacology Services
Tampa, Florida, United States, 33617
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
United States, Georgia
Center of Hope for Cancer and Blood Disorders
Riverdale, Georgia, United States, 30274
United States, Louisiana
Louisiana Research Associates
New Orleans, Louisiana, United States, 70114
United States, Maryland
The Center for Clinical Research - Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Missouri
A & A Pain Institute of St. Louis
St. Louis, Missouri, United States, 63141
Capital Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65109
United States, Montana
Office of Donald H. Berdeaux MD
Great Falls, Montana, United States, 59405
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Metropolitan Hospital Center
New York, New York, United States, 10029
United States, North Carolina
Four Seasons Hospice & Pallative Care
Flat Rock, North Carolina, United States, 28731
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Lone Star Oncology
Austin, Texas, United States, 78759
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Belgium
Jules Bordet Institute
Bruxelles, Belgium, 1000
UZ Leuven - Algologisch Centrum Anesthesiologie
Pellenberg, Belgium, 3212
CHU Charleroi (Hôpital civil de Charleroi)
Charleroi, Belgium, 6000
Canada, British Columbia
Vancouver Health Research Center
Victoria, British Columbia, Canada, V8V 1R2
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Chile
Instituto Radio-oncológico Santiago (INRAD)
Santiago, Chile
Clínica Ciudad del Mar
Viña del Mar, Chile
Czech Republic
AR klinika FN Plzen -Ambulance pro lécbu bolesti
Plzen, Czech Republic, 304 60
FN a LF UP Olomouc - Ambulance pro lécbu bolesti
Olomouc, Czech Republic, 775 20
FN Hradec Králové - Klinika onkologie a radioterapie
Hradec Králové, Czech Republic, 500 05
Nemocnice Ceské Budejovice
Ceské Budejovice, Czech Republic, 370 87
Fakultní nemocnice Na Bulovce
Praha 8 - Liben, Czech Republic, 180 81
ARO, Krajská zdravotni, K.Z. a.s, Nemocnice
Teplice, Czech Republic, 41501
Nemocnice Jihlava
Jihlava, Czech Republic, 58633
Ambulance pro lécbu bolesti, ARO
Benešov, Czech Republic, 25601
Ambulance pro lécbu bolesti
Ceské Budejovice, Czech Republic, 370 01
Finland
Docrates Clinic
Helsinki, Finland, 00150
France
Centre hospitalier Lyon Sud
Pierre-Benite, France, 69495
Praticien hospitalier
Tarbes, France, 65000
Germany
Schmerz- und Palliativzentrum Göppingen
Göppingen, Germany, 73033
Schmeiz - u Pallielivzendium Wiesbaden
Wiesbaden, Germany, 65189
RWTH Aachen Universität
Aachen, Germany, 52074
St.-Marien-Hospital Lunen
Lunen, Germany, 44534
India
Jawaharlal Nehru Cancer Hospital
Madhya Pradesh, India, 462 001
Seroc Cancer Center
Rajasthan, India, 302 013
Bhagwaan Mahaveer Cancer Hospital and Research Centre
Jaipur, India, 302017
CHL - Apollo Hospitals
Madhya Pradesh, India, 452 008
Yashoda Hospital
Andhra Pradesh, India, 500 082
Indo-American Cancer Institute and Research Center
Hyderabaad, India, 500034
Apollo Hospital
Hyderabaad, India, 500033
Deenanath Mangeshkar Hospital and Research Center
Pune, India
All India Institute of Medical Sciences
New Delhi, India, 110 029
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, India, 411001
Meenakshi Mission Hospital & Research Centre
Madurai, India, 625107
CBCC- Apollo Hospital
Gandhinagar, India
Bangalore Institute of Oncology
Bangalore,, India, 560027
Italy
Dir. S.C.D.U. Psicologia Clinica ed Oncologica
Turin, Italy, 10128
Regina Elana Cancer Institute
Rom, Italy, 00144
Mexico
Htal Ángeles de Pedregal
Mexico DF, Mexico, 10700
Hospital Aranda de la Parra
Leon, Mexico, 37000
Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Tychy, Poland, 43-100
Wielkopolskie Centrum Onkologii
Poznan, Poland, 61-866
Beskidzkie Centrum Onkologii im. Jana Pawla
Bielsko-Biala, Poland, 43-300
Poradnia Leczenia Bolu
Edyty Jakubow, Poland
NZOZ Hospicjum Milosierdzia Bozego
Gliwice, Poland, 44-101
Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie
Warszawa, Poland, 02-781
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Gdansk, Poland, 80-803
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-631
Romania
Centrul de Oncologie Medicala
Iasi, Romania, 700106
District Hospital Dr. Alexandru Simionescu
Hunedoara, Romania, 331057
Spitalul Clinic Judetean Sibiu Oncologie
Sibiu, Romania, 550245
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"
Suceava, Romania, 720237
Hospice "Casa Sperantei"
Brasov, Romania, 500074
Spitalul Municipal Onesti
Onesti, Jud. Bacau, Romania, 601048
Spitalul Universitar de Urgenta Elias
Bucuresti, Romania, 011461
Spitalul Judetean de Urgenta "Constantin Opris"
Baia Mare, Maramures, Romania, 430031
Policnica Orizont-Oncologie Medicala
Craiova, Romania, 200535
Spitalul Municipal Ploiesti
Ploiesti, Romania, 100337
Spitalul Judetean de Urgenta Braila
Braila, Jud. Braila, Romania, 810325
S.C. IanuliMed S.R.L. Oncologie Medicala
Bucuresti, Romania, 020962
South Africa
Eastleigh Breast Cancer Center
Lynnwood, South Africa, 0041
Dr. Pirjol & Szpak Inc.
Amanzimtoti, South Africa, 4126
Trialtech Research - Embassy Drive Medical Centre
Hatfield, Pretoria, South Africa, 0083
Pain Clinic
Cape Town, South Africa, 8001
Oncology/Haematology Dept Research Unit
Kimberley, South Africa, 8301
Pretoria Urology Research Unit
Hatfield, Pretoria, South Africa, 0083
Medi Clinic
Bloemfontein, South Africa, 9301
Spain
Hospital Virgen del Mar
Almeria, Spain, 04003
Hospital Universitario de Bellvitge
Feixa, Llarga, sn, Spain, 08907
Hospital Univ. Virgen de las Nieves
Granada, Spain, 180114
Hospital de la Rioja
Logrono, Spain, 26001
HU Puerta del Mar, Oncologia
Cadiz, Spain, 11009
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Los Montalvos
Salamanca, Spain, 37192
United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Fairfield General Hospital
Bury, Lancashire, United Kingdom, BL9 7TD
Weston Area Health Trust
Weston super Mare, United Kingdom, BS23 4TQ
James Paget Hospital
Gorleston on Sea, Norfolk, United Kingdom, NR31 6LA
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Edinburgh Cancer Research Centre (CRUK)
Edinburgh, United Kingdom, EH4 2XR
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6LL
International Observatory on End of Life Care
Lancaster, United Kingdom, LA1 4YT
Basingstoke & North Hampshire NHS Foundation Trust
Basingstoke, United Kingdom, RG24 9NA
Marie Curie Hospice Holme Tower
Penarth, United Kingdom, CF64 3YR
West Suffolk Hospital
Bury St Edmunds, United Kingdom, IP33 2QZ
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Quintiles
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd ( Clinical Project Manager )
Study ID Numbers: GWCA0701
Study First Received: September 13, 2007
Last Updated: October 31, 2009
ClinicalTrials.gov Identifier: NCT00530764     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GW Pharmaceuticals Ltd.:
Pain
Cancer
Palliative

ClinicalTrials.gov processed this record on November 30, 2009