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.
Verified April 2014 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: April 10, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


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
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, Alabama
Not yet recruiting
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85018
United States, California
Recruiting
Gilroy, California, United States, 95020
Not yet recruiting
La Jolla, California, United States, 92037
Recruiting
Los Angeles, California, United States, 90027
Recruiting
Los Angeles, California, United States, 90017
Not yet recruiting
Montebello, California, United States, 90640
United States, Florida
Recruiting
Daytona Beach, Florida, United States, 32117
Recruiting
Holiday, Florida, United States, 34691
Recruiting
Jacksonville, Florida, United States, 32257
Recruiting
Lynn Haven, Florida, United States, 32444
Not yet recruiting
Miami, Florida, United States, 33179
Completed
New Port Richey, Florida, United States, 34652
Recruiting
Sarasota, Florida, United States, 34238
Not yet recruiting
Tampa, Florida, United States, 33617
Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Recruiting
Marietta, Georgia, United States, 30060
Recruiting
Newman, Georgia, United States, 30265
Not yet recruiting
Riverdale, Georgia, United States, 30274
Recruiting
Stockbridge, Georgia, United States, 30281
United States, Illinois
Not yet recruiting
Chicago, Illinois, United States, 60631
Not yet recruiting
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Recruiting
Ashland, Kentucky, United States, 41101
United States, Louisiana
Recruiting
Bossier, Louisiana, United States, 71111
Recruiting
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
Not yet recruiting
Boston, Massachusetts, United States, 02115
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
Not yet recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Not yet recruiting
New York, New York, United States, 10029
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
Not yet recruiting
Middletown, Ohio, United States, 45042
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Not yet recruiting
Katy, Texas, United States, 77094
Recruiting
Laredo, Texas, United States, 78041
Not yet recruiting
San Antonio, Texas, United States, 78217
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Recruiting
Lacey, Washington, United States, 98503
Recruiting
Seattle, Washington, United States, 98101
Australia, Victoria
Recruiting
Parkville, Victoria, Australia, 3050
Australia
Recruiting
East Melbourne, Australia, 3002
Belgium
Not yet recruiting
Brasschaat, Belgium, 2930
Completed
Bruxelles, Belgium, 1000
Not yet recruiting
Charleroi, Belgium, 6000
Not yet recruiting
Gent, Belgium, 9000
Bulgaria
Completed
Gabrovo, Bulgaria, 5300
Completed
Shumen, Bulgaria, 9700
Not yet recruiting
Sofia, Bulgaria, 1784
Not yet recruiting
Stara Zagora, Bulgaria, 6003
Completed
Varna, Bulgaria, 9010
Completed
Vrasta, Bulgaria, 3000
Czech Republic
Completed
Benesov, Czech Republic, 25601
Withdrawn
Bilovec, Czech Republic, 743 01
Completed
Ceske Budejovice, Czech Republic, 370 87
Completed
Ceske Budejovice, Czech Republic, 370 01
Completed
Hradec Kralove, Czech Republic, 500 05
Completed
Most, Czech Republic, 434 64
Completed
Nemocnicni, Czech Republic, 46601
Completed
Ostrava-Poruba, Czech Republic, 708 52
Completed
Plesi, Czech Republic, 262 04
Completed
Plzen, Czech Republic, 304 60
Withdrawn
Praha 8 - Liben, Czech Republic, 180 81
Completed
Sokolov, Czech Republic, 35601
Completed
Teplice, Czech Republic, 415 01
Estonia
Withdrawn
Tallinn, Estonia, 13419
Withdrawn
Tartu, Estonia, 51014
Germany
Completed
Bad Klosterlausnitz, Germany, 07639
Completed
Berlin, Germany, 10435
Withdrawn
Bonn, Germany, 53123
Completed
Frankfurt, Germany, 60311
Completed
Jena, Germany, 07747
Completed
Lunen, Germany, 44534
Withdrawn
Rhaunen, Germany, 55624
Completed
Wetzlar, Germany, 35578
Completed
Wiesbaden, Germany, 65189
Hungary
Completed
Deszk, Hungary, H-6772
Recruiting
Gyor, Hungary, 9024
Completed
Kecskemét, Hungary, H-6000
Completed
Komarom, Hungary, H-2900
Completed
Miskolc, Hungary, H-3501
Completed
Nyíregyháza, Hungary, H-4412
Withdrawn
Nyíregyháza, Hungary, H-4400
Completed
Szekszard, Hungary, H-7100
Withdrawn
Szolnok, Hungary, H-5000
Italy
Recruiting
Torino, Italy, 10126
Latvia
Not yet recruiting
Jelgava, Latvia, LV-3001
Completed
Rezekne, Latvia, LV-4600
Completed
Riga, Latvia, LV-1038
Completed
Ventspils, Latvia, LV-3601
Lithuania
Not yet recruiting
Kaunas, Lithuania, LT-45434
Completed
Klaipeda, Lithuania, LT-92288
Completed
Siauliai, Lithuania, LT-76307
Completed
Vilnius, Lithuania, LT-08660
Not yet recruiting
Vilnius, Lithuania, LT-08661
Mexico
Withdrawn
Chihuahua, Mexico, 31203
Completed
Mexico DF, Mexico, 10700
Recruiting
Monterrey, Mexico, 64710
Poland
Completed
Bielsko-Biala, Slaskie, Poland, 43-300
Completed
Bialystok, Poland, 15-250
Completed
Bydgoszcz, Poland, 85-796
Completed
Czestochowa, Poland, 42-200
Completed
Dzialdowo, Poland, 13200
Completed
Gdansk, Poland, 80-802
Completed
Gliwice, Poland, 44-101
Completed
Klodzko, Poland, 57300
Completed
Ostrowiec Swietokrzyski, Poland, 27-400
Completed
Poznan, Poland, 61-245
Not yet recruiting
Poznan, Poland, 61-866
Not yet recruiting
Tychy, Poland, 43-100
Completed
Warsaw, Poland, 02-781
Puerto Rico
Recruiting
San Juan, Puerto Rico, 00927
Romania
Completed
Baia Mare, Romania, 430031
Completed
Braila, Romania, 810325
Completed
Brasov, Romania, 500366
Completed
Bucresti, Romania, 011461
Completed
Bucuresti, Romania, 010976
Completed
Cluj-Napoca, Romania, 400015
Completed
Craiova, Romania, 200385
Recruiting
Focsani, Romania, 620165
Recruiting
Jud Constanta, Romania, 900591
Completed
Lasi, Romania, 700106
Completed
Oradea, Romania, 410469
Completed
Satu Mare, Romania, 440055
Completed
Sibiu, Romania, 550245
Completed
Suceava, Romania, 720237
Not yet recruiting
Timisoara, Romania, 300239
Spain
Recruiting
Cadiz, Spain, 11009
Recruiting
Carrascal de Barregas, Spain, 37129
Recruiting
Granada, Spain, 18014
Completed
Logroño, Spain, 26001
Taiwan
Recruiting
Chanqhua City, Taiwan, 500
Recruiting
Taichung, Taiwan, 404
Recruiting
Tainan City, Taiwan, 73657
Recruiting
Taipei, Taiwan, 10099
Recruiting
Taipei, Taiwan, 11217
Recruiting
Taipei, Taiwan, 10449
United Kingdom
Completed
Bury, Lancashire, United Kingdom, BL9 7TD
Recruiting
Crumpsall, Manchester, United Kingdom, M8 5RB
Recruiting
Bury St. Edmunds, United Kingdom, IP33 2QZ
Completed
Coventry, United Kingdom, CV2 2HT
Withdrawn
Dumfries, United Kingdom, DG1 4AP
Completed
Edinburgh, United Kingdom, EH4 2XR
Completed
Glasgow, United Kingdom, G12 0YN
Completed
Gloucestershire, United Kingdom, GL53 0QJ
Completed
Gorleston on Sea, United Kingdom, NR31 6LA
Completed
Norwich, United Kingdom, NR4 7UY
Not yet recruiting
Nottingham, United Kingdom, NG5 1PB
Completed
Plymouth, United Kingdom, PL6 8DH
Completed
Weston Super Mare, United Kingdom, BS23 4TQ
Completed
Withington, Manchester, United Kingdom, M20 4BX
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: NCT01337089     History of Changes
Other Study ID Numbers: GWCA0999, 2009-016529-32
Study First Received: April 12, 2011
Last Updated: April 10, 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 April 17, 2014