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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
0
0
2009-016529-32
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Secondary ID [2]
0
0
GWCA0999
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
0
0
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Advanced Cancer
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nabiximols
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.
Treatment: Drugs: Nabiximols
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Of Participants With Treatment-emergent Adverse Events
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Assessment method [1]
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Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
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Timepoint [1]
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Baseline, Day 183
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Secondary outcome [1]
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Change From Baseline In Mean NRS Average Pain During The Last Period
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Assessment method [1]
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0
Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score.
A negative value indicates an improvement in average pain score from Baseline.
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Timepoint [1]
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Baseline, Last Period (Days 156-183) or last 27 days of treatment
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Secondary outcome [2]
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Change From Baseline In Mean Sleep Disruption NRS During The Last Period
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Assessment method [2]
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Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score.
A negative value indicates an improvement in sleep disruption score from Baseline.
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Timepoint [2]
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Baseline, Last Period (Days 156-183) or last 27 days of treatment
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Secondary outcome [3]
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Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
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Assessment method [3]
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The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment.
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Timepoint [3]
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Last Visit (up to Day 183)
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Secondary outcome [4]
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Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
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Assessment method [4]
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Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment.
Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.
A negative value indicates improvement in condition from Baseline.
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Timepoint [4]
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Baseline, Last Visit (up to Day 183)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/01/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/01/2016
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Sample size
Target
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Accrual to date
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Final
660
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Recruitment in Australia
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Recruitment hospital [1]
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- Parkville
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
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Name
Jazz Pharmaceuticals
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Otsuka Pharmaceutical Development & Commercialization, Inc.
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01337089
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01337089
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