Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by GW Pharmaceuticals Ltd.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01337089
First received: April 12, 2011
Last updated: March 12, 2015
Last verified: March 2015
  Purpose

This is a six-month extension study to evaluate the safety of long-term Sativex® therapy when used as an adjunctive measure in patients with advanced cancer. The study provides continued availability of Sativex® to patients who completed the preceding Phase 3 study.


Condition Intervention Phase
Pain
Advanced Cancer
Drug: Sativex®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of adverse events (AEs) coded according to the MedDRA dictionary. Descriptive presentations of treatment emergent AEs will be given by preferred term and system organ class. The number of patients reporting at least one AE will be provided.


Secondary Outcome Measures:
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Columbia Suicide Severity Rating Scale (C-SSRS) summarized by prior treatment and visit. Changes from baseline will be summarized similarly.

  • Vital Signs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Vital Signs summarized descriptively by visit and prior treatment. Changes from baseline will be summarized similarly.

  • Hematology and Biochemistry Assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hematology and Biochemistry assessments will be summarized descriptively for baseline and end of treatment, by prior treatment and overall. Summaries of the changes from baseline and categorical shift tables will also be provided.

  • Weekly average NRS Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weekly average NRS Pain scores will be summarized across time. Descriptive summaries by time (and prior treatment) of changes from baseline will also be provided. The individual patient scores will be averaged within the periods over days E8-E15, E16-E43, …E156-E183 and then summarized by period; the scores from day E1 are the baseline values.

  • Weekly average Sleep Disruption NRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weekly average Sleep Disruption NRS review scores will be analyzed analogously to the weekly average pain scores.

  • Constipation NRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Constipation NRS will be summarized by measurement time point and also as changes from baseline.

  • Patient Satisfaction Questionnaire (PSQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient Satisfaction Questionnaire (PSQ) scores will be summarized as counts (%) by measurement time-point.


Estimated Enrollment: 760
Study Start Date: January 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-comparative, open-label
Provides continued availability of Sativex® to patients who completed the preceding double blind Phase 3 studies.
Drug: Sativex®
Sativex® oromucosal spray administered orally with a spray into cheek
Other Name: nabiximols

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has completed the parent study within the last seven days
  • Willing and able to give written informed consent
  • Willing and able to comply with all study requirements

Exclusion Criteria:

  • The patient is currently using cannabis or cannabinoid based medications, other than the parent study IMP, and is unwilling to abstain for the duration of the study
  • 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 substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer)
  • Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year)
  • 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: NCT01337089

Contacts
Contact: SPRAY Study Information SPRAYInfo@mmgct.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85018
Recruiting
Phoenix, Arizona, United States, 85028
United States, California
Recruiting
El Cajon, California, United States, 92020
United States, Florida
Recruiting
Holiday, Florida, United States, 34691
Recruiting
Jacksonville, Florida, United States, 32257
Recruiting
Miami, Florida, United States, 33143
Recruiting
Stuart, Florida, United States, 34994
United States, Georgia
Recruiting
Marietta, Georgia, United States, 30060
Recruiting
Newman, Georgia, United States, 30265
Recruiting
Stockbridge, Georgia, United States, 30281
United States, Louisiana
Recruiting
Shreveport, Louisiana, United States, 71105
United States, Minnesota
Recruiting
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
Recruiting
Kansas City, Missouri, United States, 64132
United States, Montana
Recruiting
Missoula, Montana, United States, 59802
United States, New Jersey
Recruiting
Berlin, New Jersey, United States, 08009
United States, North Carolina
Recruiting
Flat Rock, North Carolina, United States, 28731
Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Recruiting
Cleveland, Ohio, United States, 44110
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Recruiting
Houston, Texas, United States, 77024
Recruiting
Houston, Texas, United States, 77089
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84124
United States, Virginia
Recruiting
Falls Church, Virginia, United States, 22042
Australia, Victoria
Recruiting
Parkville, Victoria, Australia, 3050
Australia
Completed
East Melbourne, Australia, 3002
Bulgaria
Recruiting
Gabrovo, Bulgaria, 5300
Recruiting
Shumen, Bulgaria, 9700
Recruiting
Sofia, Bulgaria, 1303
Recruiting
Varna, Bulgaria, 9010
Recruiting
Vratza, Bulgaria, 3000
Germany
Recruiting
Frankfurt, Germany, 60311
Recruiting
Lunen, Germany, 44534
Recruiting
Stadtroda, Germany, 07646
Recruiting
Wetzlar, Germany, 35578
Hungary
Recruiting
Budapest, Hungary, 1135
Recruiting
Deszk, Hungary, 6772
Recruiting
Komarom, Hungary, 2900
Recruiting
Nyíregyháza, Hungary, 4412
Recruiting
Szekszard, Hungary, 7100
Recruiting
Szikszo, Hungary, 3800
Israel
Recruiting
Ashkelon, Israel, 78306
Recruiting
Beer Sheva, Israel, 84101
Recruiting
Haifa, Israel, 31096
Recruiting
Zerifin, Israel, 60930
Italy
Recruiting
Garbagnate Milanese, Italy, 20024
Recruiting
Piacenza, Italy, 29100
Recruiting
Torino, Italy, 10126
Lithuania
Recruiting
Klaipeda, Lithuania, LT-92288
Recruiting
Siauliai, Lithuania, LT-76307
Recruiting
Vilnius, Lithuania, LT-08660
Poland
Recruiting
Bydgoszcz, Poland, 85-796
Recruiting
Czeladz, Poland, 41-250
Recruiting
Gdansk, Poland, 80-208
Recruiting
Gliwice, Poland, 44-101
Recruiting
Klodzko, Poland, 57-300
Recruiting
Opole, Poland, 45-272
Recruiting
Ostrowiec Swietokrzyski, Poland, 27-400
Recruiting
Poznan, Poland, 61-245
Recruiting
Warszawa, Poland, 02-781
Recruiting
Warszawa, Poland, 02-793
Recruiting
Wloclawek, Poland, 87-800
Puerto Rico
Recruiting
Ponce, Puerto Rico, 00717
Recruiting
San Juan, Puerto Rico, 00927
Romania
Recruiting
Alba Lulia, Romania, 510077
Recruiting
Baia Mare, Romania, 430241
Recruiting
Braila, Romania, 810325
Recruiting
Bucresti, Romania, 011461
Recruiting
Bucuresti, Romania, 010976
Recruiting
Focsani, Romania, 620165
Recruiting
Oradea, Romania, 410469
Recruiting
Satu Mare, Romania, 440055
Recruiting
Sibiu, Romania, 550245
Recruiting
Suceava, Romania, 720237
Spain
Recruiting
Carrascal de Barregas, Spain, 37129
Recruiting
Granada, Spain, 18014
Completed
Logroño, Spain, 26001
Recruiting
Madrid, Spain, 28050
Taiwan
Completed
Chanqhua City, Taiwan, 500
Recruiting
Taichung, Taiwan, 404
Recruiting
Tainan City, Taiwan, 73657
Recruiting
Taipei, Taiwan, 11217
Recruiting
Taipei, Taiwan, 11490
Completed
Taipei, Taiwan, 10099
United Kingdom
Recruiting
Bury St. Edmunds, United Kingdom, IP33 2QZ
Recruiting
Edinburgh, United Kingdom, EH42 XU
Recruiting
Glasgow, United Kingdom, G12 0YN
Recruiting
Leeds, United Kingdom, LS17 6QD
Recruiting
Manchester, United Kingdom, M20 4BX
Recruiting
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01337089     History of Changes
Other Study ID Numbers: GWCA0999, 2009-016529-32
Study First Received: April 12, 2011
Last Updated: March 12, 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
inadequate analgesia
optimized chronic opioid therapy

ClinicalTrials.gov processed this record on March 26, 2015