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

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:
NCT01262651
First received: December 16, 2010
Last updated: June 2, 2015
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.

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: July 2015
Estimated Primary Completion Date: June 2015 (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
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: NCT01262651

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85018
Phoenix, Arizona, United States, 85028
United States, California
El Cajon, California, United States, 92020
Gilroy, California, United States, 95020
United States, Florida
Brandon, Florida, United States, 33511
Daytona Beach, Florida, United States, 32117
Holiday, Florida, United States, 34691
Jacksonville, Florida, United States, 32257
Lynn Haven, Florida, United States, 32444
Miami, Florida, United States, 33143
Stuart, Florida, United States, 34994
United States, Georgia
Marietta, Georgia, United States, 30060
Newman, Georgia, United States, 30265
Stockbridge, Georgia, United States, 30281
United States, Louisiana
Shreveport, Louisiana, United States, 71105
United States, Minnesota
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
Kansas City, Missouri, United States, 64132
United States, Montana
Missoula, Montana, United States, 59802
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, North Carolina
Flat Rock, North Carolina, United States, 28731
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland, Ohio, United States, 44110
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Bellaire, Texas, United States, 77401
Houston, Texas, United States, 77024
Houston, Texas, United States, 77089
United States, Utah
Salt Lake City, Utah, United States, 84124
United States, Virginia
Falls Church, Virginia, United States, 22042
Belgium
Bruxelles, Belgium, 1000
Bulgaria
Gabrovo, Bulgaria, 5300
Shumen, Bulgaria, 9700
Sofia, Bulgaria, 1784
Stara Zagora, Bulgaria, 6003
Varna, Bulgaria, 9010
Czech Republic
Ceske Budejovice, Czech Republic, 370 87
Ceske Budejovice, Czech Republic, 370 01
Hradec Kralove, Czech Republic, 500 05
Most, Czech Republic, 434 64
Nova Ves pod Plesi 110, Czech Republic, 26 204
Ostrava-Poruba, Czech Republic, 708 52
Plzen, Czech Republic, 304 60
Germany
Bad Klosterlausnitz, Germany, 07639
Lunen, Germany, 44534
Wetlzlar, Germany, 35578
Hungary
Deszk, Hungary, H-6772
Kecskemét, Hungary, H-6000
Komarom, Hungary, H-2900
Miskolc, Hungary, H-3501
Nyíregyháza, Hungary, H-4400
Nyíregyháza, Hungary, H-4412
Szekszard, Hungary, H-7100
Latvia
Rezekne, Latvia, LV-4600
Riga, Latvia, LV-1038
Lithuania
Klaipeda, Lithuania, LT-92288
Siauliai, Lithuania, LT-76307
Vilnius, Lithuania, LT-08660
Poland
Bialystok, Poland, 15-250
Bielsko-Biala, Slaskie, Poland, 43-300
Gliwice, Poland, 44-101
Poznan, Poland, 61-245
Warszawa, Poland, 02-781
Puerto Rico
Ponce, Puerto Rico, 00717
San Juan, Puerto Rico, 00927
Romania
Baia Mare, Romania, 430031
Braila, Romania, 810325
Bucuresti, Romania, 010976
Craiova, Romania, 200385
Oradea, Romania, 410469
Satu Mare, Romania, 440055
Suceava, Romania, 720237
United Kingdom
Bury, United Kingdom, BL9 7TD
Bury St. Edmunds, United Kingdom, IP33 2QZ
Edinburgh, United Kingdom, EH4 2XR
Glasgow, United Kingdom, G12 0YN
Norwich, United Kingdom, NR4 7UY
Weston Super Mare, United Kingdom, BS23 4QT
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: June 2, 2015
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 September 02, 2015