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History of Changes for Study: NCT00530764
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)
Latest version (submitted June 13, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2007 None (earliest Version on record)
2 February 29, 2008 Recruitment Status, Study Status, Study Design, Contacts/Locations, Outcome Measures and Sponsor/Collaborators
3 July 3, 2008 Contacts/Locations and Study Status
4 July 8, 2008 Contacts/Locations and Study Status
5 July 16, 2008 Contacts/Locations and Study Status
6 July 31, 2008 Contacts/Locations and Study Status
7 September 15, 2008 Contacts/Locations and Study Status
8 October 7, 2008 Contacts/Locations and Study Status
9 October 22, 2008 Contacts/Locations and Study Status
10 October 29, 2008 Contacts/Locations and Study Status
11 November 12, 2008 Contacts/Locations and Study Status
12 November 17, 2008 Contacts/Locations and Study Status
13 November 26, 2008 Contacts/Locations and Study Status
14 December 2, 2008 Contacts/Locations and Study Status
15 December 10, 2008 Contacts/Locations and Study Status
16 February 2, 2009 Contacts/Locations and Study Status
17 May 28, 2009 Contacts/Locations, Outcome Measures and Study Status
18 July 27, 2009 Contacts/Locations, Study Status and Study Identification
19 September 15, 2009 Contacts/Locations, Eligibility and Study Status
20 September 18, 2009 Contacts/Locations and Study Status
21 October 21, 2009 Contacts/Locations and Study Status
22 October 31, 2009 Recruitment Status, Study Status and Contacts/Locations
23 November 30, 2010 Recruitment Status and Study Status
24 June 16, 2011 Outcome Measures, Arms and Interventions, Study Status, Study Design, Results and Eligibility
25 May 24, 2012 Sponsor/Collaborators and Study Status
26 June 13, 2013 Study Status and References
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Study NCT00530764
Submitted Date:  September 13, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: GWCA0701
Brief Title: A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2007
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: September 13, 2007
First Submitted that
Met QC Criteria:
September 13, 2007
First Posted: September 17, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 13, 2007
Last Update Posted: September 17, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Jazz Pharmaceuticals
Responsible Party:
Collaborators: Quintiles, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Palliative Care
Pain
Cancer
Keywords: Pain
Cancer
Palliative
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: GW-1000-02
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Matthew Hersch, MSc
Telephone: +44 (0) 1353 616600
Email: mhersch@gwpharm.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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