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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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ClinicalTrials.gov Identifier: NCT01337089
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

April 12, 2011
April 18, 2011
March 23, 2018
April 23, 2018
April 23, 2018
January 19, 2011
January 27, 2016   (Final data collection date for primary outcome measure)
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.
Incidence of adverse events (AEs) [ Time Frame: 6 months ]
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.
Complete list of historical versions of study NCT01337089 on ClinicalTrials.gov Archive Site
  • 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.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]
    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 ]
    Vital Signs summarized descriptively by visit and prior treatment. Changes from baseline will be summarized similarly.
  • Hematology and Biochemistry Assessments [ Time Frame: 6 months ]
    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 ]
    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 ]
    Weekly average Sleep Disruption NRS review scores will be analyzed analogously to the weekly average pain scores.
  • Constipation NRS [ Time Frame: 6 months ]
    Constipation NRS will be summarized by measurement time point and also as changes from baseline.
  • Patient Satisfaction Questionnaire (PSQ) [ Time Frame: 6 months ]
    Patient Satisfaction Questionnaire (PSQ) scores will be summarized as counts (%) by measurement time-point.
Not Provided
Not Provided
 
Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
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
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.

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.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pain
  • Advanced Cancer
Drug: Nabiximols
Other Name: Sativex®
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.
Intervention: Drug: Nabiximols
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
760
January 27, 2016
January 27, 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Bulgaria,   Czechia,   Germany,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Mexico,   Poland,   Puerto Rico,   Romania,   Spain,   Taiwan,   United Kingdom,   United States
Czech Republic,   Estonia
 
NCT01337089
GWCA0999
2009-016529-32 ( EudraCT Number )
Yes
Not Provided
Not Provided
GW Pharmaceuticals Ltd.
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
GW Pharmaceuticals Ltd.
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP