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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by GW Pharmaceuticals Ltd.
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: January 14, 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

Contacts
Contact: SPRAY Study Information SPRAYInfo@mmgct.com

  Hide Study Locations
Locations
United States, Alabama
Withdrawn
Birmingham, Alabama, United States, 35216
United States, California
Not yet recruiting
Fountain Valley, California, United States, 92708
Recruiting
Glendale, California, United States, 91204
Recruiting
Los Angeles, California, United States, 90017
Not yet recruiting
Riverside, California, United States, 92501
Recruiting
Santa Rosa, California, United States, 95403
United States, Florida
Recruiting
Clearwater, Florida, United States, 33756
Recruiting
Holiday, Florida, United States, 34691
Not yet recruiting
Miami, Florida, United States, 33136
Recruiting
Miami, Florida, United States, 33136
Recruiting
Stuart, Florida, United States, 34994
United States, Georgia
Recruiting
Marietta, Georgia, United States, 30060
Recruiting
Newnan, Georgia, United States, 30265
Recruiting
Stockbridge, Georgia, United States, 30281
United States, Illinois
Recruiting
Centralia, Illinois, United States, 62801
Withdrawn
Gurnee, Illinois, United States, 60031
Recruiting
Peoria, Illinois, United States, 61615
United States, Indiana
Recruiting
Evansville, Indiana, United States, 47714
Recruiting
Goshen, Indiana, United States, 46526
United States, Kansas
Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Recruiting
Ashland, Kentucky, United States, 41101
Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Recruiting
Bossier, Louisiana, United States, 71111
Recruiting
Shreveport, Louisiana, United States, 71105
United States, Mississippi
Withdrawn
Jackson, Mississippi, United States, 39202
United States, Missouri
Not yet recruiting
Saint Louis, Missouri, United States, 63136
United States, Montana
Recruiting
Missoula, Montana, United States, 59802
United States, Nebraska
Not yet recruiting
Omaha, Nebraska, United States, 68131
United States, New Jersey
Recruiting
Berlin, New Jersey, United States, 08009
Not yet recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Recruiting
New York, New York, United States, 10003
Recruiting
New York, New York, United States, 10010
United States, North Carolina
Withdrawn
Fayetteville, North Carolina, United States, 28304
United States, North Dakota
Recruiting
Bismarck, North Dakota, United States, 58501
United States, Ohio
Recruiting
Canton, Ohio, United States, 44710
Recruiting
Cleveland, Ohio, United States, 44119
United States, South Carolina
Not yet recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Recruiting
Galveston, Texas, United States, 77555
Not yet recruiting
Houston, Texas, United States, 77082
United States, Washington
Recruiting
Lacey, Washington, United States, 98503
Bulgaria
Not yet recruiting
Plovdiv, Bulgaria, 4004
Completed
Ruse, Bulgaria, 7002
Recruiting
Sofia, Bulgaria, 1233
Completed
Sofia, Bulgaria, 1606
Completed
Sofia, Bulgaria, 1784
Not yet recruiting
Varna, Bulgaria, 9010
Completed
Vratsa, Bulgaria, 3000
Czech Republic
Completed
Benešov, Czech Republic, 256 01
Completed
Hradec Kralove, Czech Republic, 500 05
Completed
Nemocnicni, Czech Republic, 466 01
Completed
Plzen, Czech Republic, 30460
Completed
Sokolov, Czech Republic, 356 01
Completed
Teplice, Czech Republic, 415 01
Completed
České Budějovice, Czech Republic, 370 87
Completed
České Budějovice, Czech Republic, 370 01
Germany
Completed
Berlin, Germany
Withdrawn
Cologne, Germany, 50937
Completed
Frankfurt, Germany
Completed
Fulda, Germany, 36039
Completed
Hannover, Germany, 30625
Withdrawn
Homburg, Germany, 66421
Completed
Jena, Germany, 07747
Withdrawn
Muchen, Germany, 81377
Withdrawn
Rostock, Germany, 18055
Withdrawn
Schwalmstadt, Germany, 34613
Not yet recruiting
Tübingen, Germany, 72076
Completed
Wiesbaden, Germany
Hungary
Completed
Komarom, Hungary, H-2900
Completed
Nyíregyháza, Hungary, H-4412
Mexico
Completed
Mexico, DF, Mexico, 10700
Completed
Mexico, DF, Mexico, 14140
Completed
Mexico, DF, Mexico, 03600
Completed
Mexico, DF, Mexico, 06720
Completed
Chihuahua, Mexico, 31203
Completed
Durango, Mexico, 34000
Completed
Durango, Mexico, 34275
Completed
Jalisco, Mexico, 45170
Completed
Monterrey N.L. C.P., Mexico, 64710
Poland
Completed
Bydgoszcz, Poland, 85-796
Withdrawn
Bytom, Poland, 41-902
Completed
Czestochowa, Poland, 42-200
Withdrawn
Dzialdowo, Poland, 13-200
Completed
Gdansk, Poland, 80-208
Completed
Klodzko, Poland, 57-300
Completed
Ostrowiec Swietokrzyski, Poland, 27-400
Completed
Poznan, Poland, 61-245
Completed
Warsaw, Poland, 02-781
Not yet recruiting
Wroclaw, Poland, 53-413
Completed
Zory, Poland, 44-240
Puerto Rico
Recruiting
Ponce, Puerto Rico, 00717
Romania
Completed
Baia Mare, Romania, 430031
Completed
Braila, Romania, 810325
Completed
Brasov, Romania, 500366
Withdrawn
Bucharest, Romania, 011172
Completed
Bucuresti, Romania, 011461
Completed
Cluj-Napoca, Romania, 400015
Completed
Constanta, Romania, 900591
Completed
Dambovita, Romania, 130095
Completed
Foscani, Romania, 620165
Completed
Lasi, Romania, 700106
Completed
Sibiu, Romania, 550245
Completed
Suceava, Romania, 720237
United Kingdom
Recruiting
Crumpsall, Manchester, United Kingdom, M8 5RB
Withdrawn
Blackpool, United Kingdom, FY2 0BG
Completed
Coventry, United Kingdom, CV2 2HT
Not yet recruiting
Edinburgh, United Kingdom, EH4 2XR
Recruiting
Glasgow, United Kingdom, G12 0YN
Recruiting
Gloucestershire, United Kingdom, GL53 0QJ
Withdrawn
Inverness, United Kingdom, IV3 5SB
Withdrawn
London, United Kingdom, SW17 0RE
Recruiting
Manchester, United Kingdom, M8 5RB
Recruiting
Norfolk, United Kingdom, NR31 6LA
Withdrawn
North Yokrshire, United Kingdom, YO12 6QL
Recruiting
Norwich, United Kingdom, NR4 7UY
Withdrawn
Nottingham, United Kingdom, NG17 4HJ
Recruiting
Plymouth, United Kingdom, PL6 8DH
Withdrawn
Preston, United Kingdom, PR5 5XU
Not yet recruiting
Shropshire, United Kingdom, SY3 8HS
Withdrawn
Surrey, United Kingdom, GU2 7XX
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: January 14, 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 September 29, 2014