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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.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pain
Advanced Cancer
Intervention: Drug: Nabiximols

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled in this study included those who had taken part in studies NCT01262651 (GWCA0958), NCT01361607 (GWCA0962), and NCT01424566 (GWCA1103) and who chose to continue treatment by enrolling in this study, as well as new (de novo) participants who met all inclusion criteria and did not meet any of the exclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For the de novo participants enrolled in this study, a screening visit took place 3 to 14 days prior to enrollment.

Reporting Groups
  Description
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 milligram [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.

Participant Flow:   Overall Study
    Nabiximols
STARTED   660 
Received at Least 1 Dose of Study Drug   660 
Safety Population   660 
Efficacy Dataset   659 [1] 
COMPLETED   256 
NOT COMPLETED   404 
Adverse Event                237 
Withdrawal by Subject                129 
Withdrawal by Investigator                33 
Met Withdrawal Criteria                3 
Lost to Follow-up                2 
[1] One participant withdrew after administering nabiximols, but no efficacy data were collected.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: All participants who received at least 1 dose of nabiximols.

Reporting Groups
  Description
Nabiximols Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):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.

Baseline Measures
   Nabiximols 
Overall Participants Analyzed 
[Units: Participants]
 660 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      313  47.4% 
Male      347  52.6% 


  Outcome Measures

1.  Primary:   Percent Of Participants With Treatment-emergent Adverse Events   [ Time Frame: Baseline, Day 183 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)   [ Time Frame: Last Visit (up to Day 183) ]

5.  Secondary:   Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)   [ Time Frame: Baseline, Last Visit (up to Day 183) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Enquiries
Organization: GW Pharmaceuticals Ltd.
e-mail: medinfo.USA@gwpharm.com



Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01337089     History of Changes
Other Study ID Numbers: GWCA0999
2009-016529-32 ( EudraCT Number )
First Submitted: April 12, 2011
First Posted: April 18, 2011
Results First Submitted: March 23, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018