A Study of Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

This study is currently recruiting participants.
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:
NCT01262651
First received: December 16, 2010
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
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, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Study of Sativex® in Relieving Persistent 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: December 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262651

Contacts
Contact: SPRAY Study Information SPRAYInfo@mmgct.com

  Hide Study Locations
Locations
United States, Alabama
Not yet recruiting
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85018
United States, California
Recruiting
Carmichael, California, United States, 95608
Recruiting
El Cajon, California, United States, 92020
Recruiting
Gilroy, California, United States, 95020
Recruiting
La Jolla, California, United States, 92037
Withdrawn
Montebello, California, United States, 90640
Recruiting
Montebello, California, United States, 90640
United States, Florida
Recruiting
Daytona Beach, Florida, United States, 32117
Recruiting
Jacksonville, Florida, United States, 32257
Recruiting
Lynn Haven, Florida, United States, 32444
Not yet recruiting
Miami, Florida, United States, 33179
Recruiting
Sarasota, Florida, United States, 34238
Withdrawn
Tampa, Florida, United States, 33617
Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Recruiting
Stockbridge, Georgia, United States, 30281
United States, Illinois
Completed
Chicago, Illinois, United States, 60631
Withdrawn
Park Ridge, Illinois, United States, 60068
United States, Indiana
Recruiting
Goshen, Indiana, United States, 76526
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
Recruiting
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Recruiting
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
Recruiting
Kansas City, Missouri, United States, 64132
United States, Montana
Completed
Great Falls, Montana, United States, 59405
United States, New Jersey
Not yet recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Not yet recruiting
New York, New York, United States, 10029
Not yet recruiting
New York, New York, United States, 10003
United States, North Carolina
Recruiting
Flat Rock, North Carolina, United States, 28731
Recruiting
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Completed
Middletown, Ohio, United States, 45042
United States, Oregon
Withdrawn
Bend, Oregon, United States, 97701
United States, Pennsylvania
Recruiting
Danville, Pennsylvania, United States, 17822
Recruiting
Philadelphia, Pennsylvania, United States, 19146
United States, South Carolina
Recruiting
North Charleston, South Carolina, United States, 29406
United States, Texas
Not yet recruiting
Katy, Texas, United States, 77094
Recruiting
Laredo, Texas, United States, 78041
Recruiting
San Antonio, Texas, United States, 78217
United States, Utah
Completed
Salt Lake City, Utah, United States, 84112
Belgium
Withdrawn
Brasschaat, Belgium, 2930
Completed
Bruxelles, Belgium, 1000
Withdrawn
Charleroi, Belgium, 6000
Bulgaria
Completed
Gabrovo, Bulgaria, 5300
Completed
Shumen, Bulgaria, 9700
Not yet recruiting
Sofia, Bulgaria, 1784
Completed
Stara Zagora, Bulgaria, 6003
Completed
Varna, Bulgaria, 9010
Czech Republic
Withdrawn
Bilovec, Czech Republic, 74 301
Completed
Ceske Budejovice, Czech Republic, 370 01
Completed
Ceske Budejovice, Czech Republic, 370 87
Completed
Hradec Kralove, Czech Republic, 500 05
Completed
Most, Czech Republic, 434 64
Completed
Nova Ves pod Plesi 110, Czech Republic, 26 204
Completed
Ostrava-Poruba, Czech Republic, 708 52
Completed
Plzen, Czech Republic, 304 60
Withdrawn
Praha 8 - Liben, Czech Republic, 180 81
Estonia
Withdrawn
Tallinn, Estonia, 13419
Withdrawn
Tartu, Estonia, 51014
Germany
Completed
Bad Klosterlausnitz, Germany, 07639
Withdrawn
Bonn, Germany, 53123
Completed
Lunen, Germany, 44534
Withdrawn
Rhaunen, Germany, 55624
Completed
Wetlzlar, Germany, 35578
Hungary
Completed
Deszk, Hungary, H-6772
Completed
Kecskemét, Hungary, H-6000
Completed
Komarom, Hungary, H-2900
Completed
Miskolc, Hungary, H-3501
Completed
Nyíregyháza, Hungary, H-4400
Completed
Nyíregyháza, Hungary, H-4412
Completed
Szekszard, Hungary, H-7100
Withdrawn
Szolnok, Hungary, H-5000
Latvia
Withdrawn
Jelgava, Latvia, LV-3001
Completed
Rezekne, Latvia, LV-4600
Completed
Riga, Latvia, LV-1038
Withdrawn
Ventspils, Latvia, LV-3601
Lithuania
Withdrawn
Kaunas, Lithuania, LT-45434
Completed
Klaipeda, Lithuania, LT-92288
Completed
Siauliai, Lithuania, LT-76307
Withdrawn
Vilnius, Lithuania, LT-08661
Completed
Vilnius, Lithuania, LT-08660
Poland
Completed
Bialystok, Poland, 15-250
Completed
Bielsko-Biala, Slaskie, Poland, 43-300
Withdrawn
Gdansk, Poland, 80-803
Completed
Gliwice, Poland, 44-101
Withdrawn
Poznan, Poland, 61-866
Completed
Poznan, Poland, 61-245
Withdrawn
Tychy, Poland, 43-100
Completed
Warszawa, Poland, 02-781
Puerto Rico
Recruiting
San Juan, Puerto Rico, 00927
Romania
Completed
Baia Mare, Romania, 430031
Completed
Braila, Romania, 810325
Completed
Bucuresti, Romania, 010976
Completed
Craiova, Romania, 200385
Completed
Oradea, Romania, 410469
Completed
Satu Mare, Romania, 440055
Completed
Suceava, Romania, 720237
Withdrawn
Timisoara, Romania, 300239
United Kingdom
Completed
Bury, United Kingdom, BL9 7TD
Completed
Bury St. Edmunds, United Kingdom, IP33 2QZ
Withdrawn
Dumfries, United Kingdom, DG1 4AP
Completed
Edinburgh, United Kingdom, EH4 2XR
Completed
Glasgow, United Kingdom, G12 0YN
Withdrawn
Manchester, United Kingdom, M8 5RB
Completed
Norwich, United Kingdom, NR4 7UY
Withdrawn
Nottingham, United Kingdom, NG5 1PB
Completed
Weston Super Mare, United Kingdom, BS23 4QT
Completed
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01262651     History of Changes
Other Study ID Numbers: GWCA0958, 2009-016064-36
Study First Received: December 16, 2010
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

ClinicalTrials.gov processed this record on April 17, 2014