Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by GW Pharmaceuticals Ltd.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01337089
First received: April 12, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This is a six-month extension study to evaluate the safety of long-term Sativex® therapy when used as an adjunctive measure in patients with advanced cancer. The study provides continued availability of Sativex® to patients who completed the preceding Phase 3 study.


Condition Intervention Phase
Pain
Advanced Cancer
Drug: Sativex®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Vital Signs summarized descriptively by visit and prior treatment. Changes from baseline will be summarized similarly.

  • Hematology and Biochemistry Assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Weekly average Sleep Disruption NRS review scores will be analyzed analogously to the weekly average pain scores.

  • Constipation NRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Constipation NRS will be summarized by measurement time point and also as changes from baseline.

  • Patient Satisfaction Questionnaire (PSQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient Satisfaction Questionnaire (PSQ) scores will be summarized as counts (%) by measurement time-point.


Estimated Enrollment: 760
Study Start Date: January 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-comparative, open-label
Provides continued availability of Sativex® to patients who completed the preceding double blind Phase 3 studies.
Drug: Sativex®
Sativex® oromucosal spray administered orally with a spray into cheek
Other Name: nabiximols

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has 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 patient is currently using cannabis or cannabinoid based medications, other than the parent study IMP, and is 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)
  • Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year)
  • Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
  • Has significantly impaired renal function
  • Has significantly impaired hepatic function
  • Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337089

Contacts
Contact: SPRAY Study Information SPRAYInfo@mmgct.com

  Show 154 Study Locations
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01337089     History of Changes
Other Study ID Numbers: GWCA0999, 2009-016529-32
Study First Received: April 12, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GW Pharmaceuticals Ltd.:
cancer pain
opioid therapy
inadequate analgesia
optimized chronic opioid therapy

ClinicalTrials.gov processed this record on October 23, 2014