ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)

This study is currently recruiting participants.
Study NCT00530764.   Last updated on September 15, 2008.   Information provided by GW Pharmaceuticals Ltd.

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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.
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
Study Phase Phase II
Study Type  Interventional
Study Design  Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Primary Outcome Measure  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 Measure  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)
Condition  Palliative Care
Pain
Cancer
Intervention  Drug: GW-1000-02
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  336
Start Date  November 2007
Completion Date October 2009
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Matthew Hersch, MSc     +44 (0) 1353 616600     mhersch@gwpharm.com    
Contact: Michele Ball     +1 484-552-8329     Michele.Ball@Quintiles.com    
Location Countries  United States,   Canada,   Czech Republic,   Romania
Administrative Information Fields
NCT ID  NCT00530764
Organization ID GWCA0701
Secondary IDs ††
Study Sponsor  GW Pharmaceuticals Ltd.
Collaborators †† Quintiles
Investigators 
Information Provided By GW Pharmaceuticals Ltd.
Verification Date July 2008
First Received Date  September 13, 2007
Last Updated Date September 15, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers