Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
|ClinicalTrials.gov Identifier: NCT01337089|
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain Advanced Cancer||Drug: Nabiximols||Phase 3|
This was a 6-month, multicenter, non-comparative, OLE study to evaluate the safety of long-term nabiximols use as an adjunctive measure in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding double-blind phase 3 study and de novo participants. Consenting eligible participants entered the extension study (Day 1) on the same day as the "end of treatment" visit of a parent study or within 7 days of the "end of treatment" visit or on the day of the "safety follow-up visit" of the parent study. The "safety follow-up" visit of a parent study was performed on the same day as Day 1, if the participant did not enter the OLE study on the same day as the "end of treatment" visit of a parent study. De novo participants attended a screening visit 3 to 14 days prior to enrollment (Day 1). All participants commenced dosing on Day 1. Further study visits took place after 2 weeks (Day 15), and every 4 weeks thereafter until the end of treatment period on Day 183 or earlier if the participant withdrew from the study.
Treatment was started as a single spray in the evening on the first day (Day 1). Participants then gradually titrated by 1 additional spray per day to an individualized dose, balancing efficacy and tolerability. Participants had to complete titration within 14 days of their first dose of study drug and then continue at the same dose for the remainder of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||660 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||January 19, 2011|
|Actual Primary Completion Date :||January 27, 2016|
|Actual Study Completion Date :||January 27, 2016|
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.
Other Name: Sativex®
- Percent Of Participants With Treatment-emergent Adverse Events [ Time Frame: Baseline, Day 183 ]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.
- Change From Baseline In Mean NRS Average Pain During The Last Period [ Time Frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment ]
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.
- Change From Baseline In Mean Sleep Disruption NRS During The Last Period [ Time Frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment ]
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.
- Patient Satisfaction Questionnaire At Last Visit (Up To Day 183) [ Time Frame: Last Visit (up to Day 183) ]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.
- Change From Baseline In NRS Constipation At Last Visit (Up To Day 183) [ Time Frame: Baseline, Last Visit (up to Day 183) ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337089
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