Phase 3
Completed N=660
Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Source: ClinicalTrials.gov NCT01337089 ↗Enrolled (actual)
660
Serious AEs
45.6%
Results posted
Apr 2018
Primary outcomePrimary: Percent Of Participants With Treatment-emergent Adverse Events — 82.9 percent of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Of Participants With Treatment-emergent Adverse Events |
82.9 | — |
| SECONDARY Change From Baseline In Mean NRS Average Pain During The Last Period |
0.0 | — |
| SECONDARY Change From Baseline In Mean Sleep Disruption NRS During The Last Period |
0.1 | — |
| SECONDARY Patient Satisfaction Questionnaire At Last Visit (Up To Day 183) |
56; 230; 185; 82; 33; 22 | — |
| SECONDARY Change From Baseline In NRS Constipation At Last Visit (Up To Day 183) |
-0.1 | — |
Eligibility Criteria
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
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)
Data sourced from ClinicalTrials.gov (NCT01337089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.