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

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ClinicalTrials.gov Identifier: NCT01337089
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : April 15, 2016
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Advanced Cancer Drug: Sativex® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2011
Primary Completion Date : January 2016
Study Completion Date : January 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: 6 months ]
    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 :
  1. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]
    Columbia Suicide Severity Rating Scale (C-SSRS) summarized by prior treatment and visit. Changes from baseline will be summarized similarly.

  2. Vital Signs [ Time Frame: 6 months ]
    Vital Signs summarized descriptively by visit and prior treatment. Changes from baseline will be summarized similarly.

  3. Hematology and Biochemistry Assessments [ Time Frame: 6 months ]
    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.

  4. Weekly average NRS Pain [ Time Frame: 6 months ]
    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.

  5. Weekly average Sleep Disruption NRS [ Time Frame: 6 months ]
    Weekly average Sleep Disruption NRS review scores will be analyzed analogously to the weekly average pain scores.

  6. Constipation NRS [ Time Frame: 6 months ]
    Constipation NRS will be summarized by measurement time point and also as changes from baseline.

  7. Patient Satisfaction Questionnaire (PSQ) [ Time Frame: 6 months ]
    Patient Satisfaction Questionnaire (PSQ) scores will be summarized as counts (%) by measurement time-point.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337089

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85018
Phoenix, Arizona, United States, 85028
United States, California
El Cajon, California, United States, 92020
United States, Florida
Holiday, Florida, United States, 34691
Jacksonville, Florida, United States, 32257
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
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
Australia, Victoria
Parkville, Victoria, Australia, 3050
East Melbourne, Australia, 3002
Gabrovo, Bulgaria, 5300
Shumen, Bulgaria, 9700
Sofia, Bulgaria, 1303
Varna, Bulgaria, 9010
Vratza, Bulgaria, 3000
Frankfurt, Germany, 60311
Lunen, Germany, 44534
Stadtroda, Germany, 07646
Wetzlar, Germany, 35578
Budapest, Hungary, 1135
Deszk, Hungary, 6772
Komarom, Hungary, 2900
Nyíregyháza, Hungary, 4412
Szekszard, Hungary, 7100
Szikszo, Hungary, 3800
Ashkelon, Israel, 78306
Beer Sheva, Israel, 84101
Haifa, Israel, 31096
Zerifin, Israel, 60930
Garbagnate Milanese, Italy, 20024
Piacenza, Italy, 29100
Torino, Italy, 10126
Klaipeda, Lithuania, LT-92288
Siauliai, Lithuania, LT-76307
Vilnius, Lithuania, LT-08660
Bydgoszcz, Poland, 85-796
Czeladz, Poland, 41-250
Gdansk, Poland, 80-208
Gliwice, Poland, 44-101
Klodzko, Poland, 57-300
Opole, Poland, 45-272
Ostrowiec Swietokrzyski, Poland, 27-400
Poznan, Poland, 61-245
Warszawa, Poland, 02-781
Warszawa, Poland, 02-793
Wloclawek, Poland, 87-800
Puerto Rico
Ponce, Puerto Rico, 00717
San Juan, Puerto Rico, 00927
Alba Lulia, Romania, 510077
Baia Mare, Romania, 430241
Braila, Romania, 810325
Bucresti, Romania, 011461
Bucuresti, Romania, 010976
Focsani, Romania, 620165
Oradea, Romania, 410469
Satu Mare, Romania, 440055
Sibiu, Romania, 550245
Suceava, Romania, 720237
Carrascal de Barregas, Spain, 37129
Granada, Spain, 18014
Logroño, Spain, 26001
Madrid, Spain, 28050
Chanqhua City, Taiwan, 500
Taichung, Taiwan, 404
Tainan City, Taiwan, 73657
Taipei, Taiwan, 10099
Taipei, Taiwan, 11217
Taipei, Taiwan, 11490
United Kingdom
Bury St. Edmunds, United Kingdom, IP33 2QZ
Edinburgh, United Kingdom, EH42 XU
Glasgow, United Kingdom, G12 0YN
Leeds, United Kingdom, LS17 6QD
Manchester, United Kingdom, M20 4BX
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01337089     History of Changes
Other Study ID Numbers: GWCA0999
2009-016529-32 ( EudraCT Number )
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms