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
Last Update Posted : April 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain Advanced Cancer||Drug: Sativex®||Phase 3|
|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 (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Non-comparative, open-label
Provides continued availability of Sativex® to patients who completed the preceding double blind Phase 3 studies.
Sativex® oromucosal spray administered orally with a spray into cheek
Other Name: nabiximols
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337089
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