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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01337089




Registration number
NCT01337089
Ethics application status
Date submitted
12/04/2011
Date registered
18/04/2011
Date last updated
12/04/2023

Titles & IDs
Public title
Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Scientific title
A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Secondary ID [1] 0 0
2009-016529-32
Secondary ID [2] 0 0
GWCA0999
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Advanced Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Non-comparative, open-label Nabiximols - Nabiximols was self-administered by participants as a 100 microliter (µL) oromucosal spray, in the morning and evening, up to a maximum of 10 sprays per day for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 µL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Of Participants With Treatment-emergent Adverse Events
Timepoint [1] 0 0
Baseline, Day 183
Secondary outcome [1] 0 0
Change From Baseline In Mean NRS Average Pain During The Last Period
Timepoint [1] 0 0
Baseline, Last Period (Days 156-183) or last 27 days of treatment
Secondary outcome [2] 0 0
Change From Baseline In Mean Sleep Disruption NRS During The Last Period
Timepoint [2] 0 0
Baseline, Last Period (Days 156-183) or last 27 days of treatment
Secondary outcome [3] 0 0
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Timepoint [3] 0 0
Last Visit (up to Day 183)
Secondary outcome [4] 0 0
Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
Timepoint [4] 0 0
Baseline, Last Visit (up to Day 183)

Eligibility
Key inclusion criteria
* Participant had 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The participant was using cannabis or cannabinoid based medications, other than the parent study investigational medicinal product (IMP), and was 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), current heavy alcohol consumption (more than 60 grams [g] of pure alcohol per day for men, and more than 40 g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug
* Had poorly controlled epilepsy or recurrent seizures (for example, one or more seizure during the last year)
* Had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
* Had significantly impaired renal function
* Had significantly impaired hepatic function at the "end of treatment" visit of the parent study
* Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom should not have been used in conjunction with a female condom as this may not have proven effective)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2016
Sample size
Target
Accrual to date
Final
660
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Kentucky
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Louisiana
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Minnesota
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United States of America
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Missouri
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Montana
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Utah
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United States of America
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Washington
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Belgium
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Bruxelles
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Bulgaria
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Gabrovo
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Bulgaria
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Varna
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Bulgaria
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Vratsa
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Czechia
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Benešov
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Czechia
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Jablonec Nad Nisou
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Czechia
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Most
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Czechia
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Nová Ves Pod Pleší
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Czechia
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Ostrava
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Czechia
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Plzen
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Czechia
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Sokolov
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Czechia
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Teplice
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Czechia
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Ceské Budejovice
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Jena
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Germany
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Lunen
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Germany
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Stadtroda
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Germany
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Wetzlar
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Germany
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Wiesbaden
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Hungary
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Deszk
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Hungary
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Komarom
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Hungary
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Miskolc
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Hungary
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Nyíregyháza
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Hungary
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Szekszard
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Hungary
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Szikszo
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Ramat Gan
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Israel
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Zerifin
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Italy
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Garbagnate Milanese
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Italy
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Piacenza
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Italy
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Torino
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Latvia
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Riga
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Latvia
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Rezekne
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Lithuania
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Klaipeda
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Lithuania
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Siauliai
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Lithuania
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Vilnius
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Mexico
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Chihuahua
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Mexico
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Distrito Federal
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Poland
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Bialystok
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Bielsko-Biala
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Bydgoszcz
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Czeladz
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Czestochowa
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Dzialdowo
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Gdansk
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Gliwice
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Klodzko
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Opole
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Ostrowiec Swietokrzyski
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Poznan
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Poland
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Warszawa
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Poland
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Wloclawek
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Romania
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Baia Mare
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Romania
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Braila
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Constanta
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Romania
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Craiova
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Romania
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Focsani
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Satu Mare
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Romania
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Sibiu
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Romania
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Suceava
Country [87] 0 0
Romania
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Târgoviste
Country [88] 0 0
Spain
State/province [88] 0 0
Granada
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taichung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Tainan City
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Bury Saint Edmunds
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Bury
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Cheltenham
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United Kingdom
State/province [94] 0 0
Crumpsall
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United Kingdom
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Edinburgh
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Gorleston-on-Sea
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Leeds
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Manchester
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United Kingdom
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Norwich
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United Kingdom
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Plymouth
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Weston-super-Mare
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Withington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jazz Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.
Trial website
https://clinicaltrials.gov/study/NCT01337089
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01337089