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

This study is currently recruiting participants.
Verified by GW Pharmaceuticals Ltd., July 2008

Sponsors and Collaborators: GW Pharmaceuticals Ltd.
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

Genetics Home Reference related topics:   Benign Tumors   Cancer  

MedlinePlus related topics:   Cancer  

ChemIDplus related topics:   Cannabis   GW-1000  

U.S. FDA Resources

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.

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) during the last three days of week 5.

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 2008
Estimated Primary Completion Date:   November 2008 (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.
  • The patient is currently using two or more types of break-through opioid analgesia (IR).
  • 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

Contacts
Contact: Matthew Hersch, MSc     +44 (0) 1353 616600     mhersch@gwpharm.com    
Contact: Don Gould     +1 252-478-6675     Don.Gould@Quintiles.com    

Locations
United States, Alabama
Cancer Care Center of Tuscaloosa     Recruiting
      Tuscaloosa, Alabama, United States, 35406
      Contact: Diane Ramsey-Paige, RN     205-752-0916     paiged@globalctlink.com    
      Principal Investigator: Dr Shelby Sanford            
United States, Arizona
Desert Oasis Cancer Center     Recruiting
      Casa Grande, Arizona, United States, 85222
      Contact: Diane     520-876-5770     dthebuckwheat@aol.com    
      Principal Investigator: Dr Don Hill            
United States, California
Office of Dr. Ronald Yanagihara     Recruiting
      Gilroy, California, United States, 95020
      Contact: Michiko Beck     408-847-6194     michikobeck@aol.com    
      Principal Investigator: Dr Ronald Yanagihara            
Loma Linda University     Recruiting
      Loma Linda, California, United States, 92354
      Contact: Ugonna Ihenacho     909-558-6441     uihenacho@llu.edu    
      Principal Investigator: Dr Lowell Reynolds            
United States, Florida
Tampa General Hospital     Recruiting
      Tampa, Florida, United States, 33606
      Contact: Jennifer Cooper     813-844-4218     jcooper@health.usf.edu    
      Principal Investigator: Dr Alexander Rosemurgy            
United States, Louisiana
Louisiana Research Associates     Recruiting
      New Orleans, Louisiana, United States, 70114
      Contact: Brtuno Jubelin     504-363-7448     bjubelin@lrainc.net    
      Principal Investigator: Dr Michael Biunno            
United States, Maryland
The Center for Clinical Research - Washington County Hospital     Recruiting
      Hagerstown, Maryland, United States, 21740
      Contact: Kathleen Renne     301-790-8598     krenee@wchsys.org    
      Principal Investigator: Dr Mark Yacyk            
United States, Missouri
A & A Pain Institute of St. Louis     Recruiting
      St. Louis, Missouri, United States, 63141
      Contact: Todd C Furesz     314-692-7246 ext 3     tofuresz@aapain.net    
      Principal Investigator: Dr Edwin Dunteman            
United States, Montana
Office of Donald H. Berdeaux MD     Recruiting
      Great Falls, Montana, United States, 59405
      Contact: Cindee Herman     406-731-8214     cindeelg@benefis.net    
      Principal Investigator: Dr Donald Berdeaux            
United States, North Carolina
Four Seasons Hospice & Pallative Care     Recruiting
      Flat Rock, North Carolina, United States, 28731
      Contact: Lisa Massie     828-692-6178     lmassie@nchospice.com    
      Principal Investigator: Dr Janet Bull            
Center for Clinical Research     Recruiting
      Winston-Salem, North Carolina, United States, 27103
      Contact: John Darnell     336-714-8389     jdarnell@ccrpain.com    
      Principal Investigator: Dr Richard Rauck            
United States, Ohio
Gabrail Cancer Center     Recruiting
      Canton, Ohio, United States, 44718
      Contact: Carrie Smith     330-492-3345     csmith@gabrailcancercenter.com    
      Principal Investigator: Dr Nashat Gabrail            
Summa Health System     Recruiting
      Akron, Ohio, United States, 44304
      Contact: Nancy Rinella     330-375-3440     RinellaN@summa-health.org    
      Principal Investigator: Dr William Demas            
Gabrail Cancer Center     Recruiting
      Dover, Ohio, United States, 44622
      Contact: Carrie Smith     330-492-3345     csmith@gabrailcancercenter.com    
      Sub-Investigator: Dr Nagaprasad Nagajothi            
United States, Oklahoma
Oklahoma Gynecologic Oncology     Recruiting
      Oklahoma City, Oklahoma, United States, 73112
      Contact: Gary Dean Parker     405-936-5848     gpmpkpkpaw@yahoo.com    
      Principal Investigator: Dr. Jeffrey Smith            
United States, South Carolina
Santee Hematology Oncology     Recruiting
      Sumter, South Carolina, United States, 29150
      Contact: Renee McCoy     803-934-8833     rmsanteeoncology@yahoo.com    
      Principal Investigator: Dr. Billy Clowney            
United States, Texas
Lone Star Oncology     Recruiting
      Austin, Texas, United States, 78759
      Contact: Marta Johnson     512-343-2103     martaj@lonestaroncology.com    
      Principal Investigator: Dr Brian Shimkus            
Canada, Manitoba
Cancer Care Manitoba     Recruiting
      Winnipeg, Manitoba, Canada, R2H 2A6
      Contact: Laurel Johnston     204-235-3394     laurel.johnston@cancercare.mb.ca    
      Principal Investigator: Dr Paul Daeninck            
Canada, Quebec
Jewish General Hospital     Recruiting
      Montreal, Quebec, Canada, H3T 1E2
      Contact: Nessrine Hanna     514-340-8222 ext 4301     nhanna@jgh.mcgill.ca    
      Principal Investigator: Dr Bernard Lapointe            

Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Quintiles
  More Information

Responsible Party:   GW Pharmaceuticals Ltd ( Clinical Project Manager )
Study ID Numbers:   GWCA0701
First Received:   September 13, 2007
Last Updated:   July 3, 2008
ClinicalTrials.gov Identifier:   NCT00530764
Health Authority:   United States: Food and Drug Administration

Keywords provided by GW Pharmaceuticals Ltd.:
Pain  
Cancer  
Palliative  

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on July 08, 2008




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