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Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer (SPRAY III)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01361607
First received: May 25, 2011
Last updated: November 3, 2014
Last verified: January 2014
  Purpose

This nine week study will aim to determine the efficacy, safety and tolerability of Sativex® as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in patients with advance cancer.

Eligible patients will not be required to stop any of their current treatments or medications.


Condition Intervention Phase
Pain
Advanced Cancer
Drug: Sativex®
Drug: Placebo (GA-0034)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo-controlled, Parallel Group Study of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic 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 endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean NRS average pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean NRS worst pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean Sleep Disruption NRS [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: May 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (GA-0034)
Patients will be randomized to receive either Sativex® or placebo using a 1:1 allocation ratio.
Drug: Placebo (GA-0034)
Administered orally with a spray into cheek
Experimental: Sativex®
Patients will be randomized to receive either Sativex® or placebo using a 1:1 allocation ratio.
Drug: Sativex®
Administered orally with a spray into cheek (100 μl oromucosal spray administered twice daily up to a maximum of 10 sprays per day)
Other Name: Nabiximols

  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 cancer for which there is no known curative therapy
  • The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
  • The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations
  • The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
  • The patient is using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

  • Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
  • The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
  • Has experienced myocardial infarction or clinically significant 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 significant arrhythmia or myocardial infarction
  • Has significantly impaired renal function
  • Has significantly impaired hepatic function
  • Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361607

  Hide Study Locations
Locations
United States, California
Glendale, California, United States, 91024
Santa Rosa, California, United States, 95403
United States, Florida
Clearwater, Florida, United States, 33756
Holiday, Florida, United States, 34691
Miami, Florida, United States, 33136
Stuart, Florida, United States, 34994
United States, Georgia
Marietta, Georgia, United States, 30060
Newnan, Georgia, United States, 30265
Stockbridge, Georgia, United States, 30281
United States, Illinois
Gurnee, Illinois, United States, 60031
Mount Vernon, Illinois, United States, 62864
Peoria, Illinois, United States, 61615
United States, Indiana
Evansville, Indiana, United States, 47714
Goshen, Indiana, United States, 46526
United States, Kentucky
Ashland, Kentucky, United States, 41101
Louisville, Kentucky, United States, 40207
United States, Louisiana
Bossier, Louisiana, United States, 71111
Shreveport, Louisiana, United States, 71105
United States, Montana
Missoula, Montana, United States, 59802
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, New York
New York, New York, United States, 10003
New York, New York, United States, 10010
United States, Ohio
Canton, Ohio, United States, 44710
Cleveland, Ohio, United States, 44119
United States, Texas
Galveston, Texas, United States, 77555
United States, Washington
Lacey, Washington, United States, 98503
Bulgaria
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1784
Vratsa, Bulgaria, 3000
Czech Republic
Benešov, Czech Republic, 256 01
Hradec Kralove, Czech Republic, 500 05
Nemocnicni, Czech Republic, 466 01
Plzen, Czech Republic, 30460
Sokolov, Czech Republic, 356 01
Teplice, Czech Republic, 415 01
České Budějovice, Czech Republic, 370 87
České Budějovice, Czech Republic, 370 01
Germany
Berlin, Germany
Frankfurt, Germany
Fulda, Germany, 36039
Hannover, Germany, 30625
Jena, Germany, 07747
Wiesbaden, Germany
Hungary
Komarom, Hungary, H-2900
Nyíregyháza, Hungary, H-4412
Mexico
Mexico, DF, Mexico, 14140
Mexico, DF, Mexico, 10700
Mexico, DF, Mexico, 03600
Mexico, DF, Mexico, 06720
Chihuahua, Mexico, 31203
Durango, Mexico, 34275
Durango, Mexico, 34000
Jalisco, Mexico, 45170
Monterrey N.L. C.P., Mexico, 64710
Poland
Bydgoszcz, Poland, 85-796
Czestochowa, Poland, 42-200
Gdansk, Poland, 80-208
Klodzko, Poland, 57-300
Ostrowiec Swietokrzyski, Poland, 27-400
Poznan, Poland, 61-245
Warsaw, Poland, 02-781
Zory, Poland, 44-240
Puerto Rico
Ponce, Puerto Rico, 00717
Romania
Baia Mare, Romania, 430031
Braila, Romania, 810325
Brasov, Romania, 500366
Bucuresti, Romania, 011461
Cluj-Napoca, Romania, 400015
Constanta, Romania, 900591
Dambovita, Romania, 130095
Foscani, Romania, 620165
Lasi, Romania, 700106
Sibiu, Romania, 550245
Suceava, Romania, 720237
United Kingdom
Crumpsall, Manchester, United Kingdom, M8 5RB
Coventry, United Kingdom, CV2 2HT
Glasgow, United Kingdom, G12 0YN
Gloucestershire, United Kingdom, GL53 0QJ
Manchester, United Kingdom, M8 5RB
Norfolk, United Kingdom, NR31 6LA
Norwich, United Kingdom, NR4 7UY
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01361607     History of Changes
Other Study ID Numbers: GWCA0962, 2009-016065-29
Study First Received: May 25, 2011
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GW Pharmaceuticals Ltd.:
Cancer pain
Opioid therapy
inadequate analgesia
optimized chronic opioid therapy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014