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Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer (SPRAY III)

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ClinicalTrials.gov Identifier: NCT01361607
Recruitment Status : Completed
First Posted : May 27, 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: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Pain
Advanced Cancer
Interventions: Drug: Nabiximols
Drug: Placebo (GA-0034)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Per the Statistical Analyses Plan, all randomized participants who received at least 1 dose of study drug were analyzed in the Intent to Treat (ITT) population as per randomized treatment group. However, if a participant randomized to placebo ever took a nabiximols dose, the participant was analyzed as nabiximols-treated in the Safety population.

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 5 weeks. 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.
Placebo (GA-0034) Placebo 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 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.

Participant Flow:   Overall Study
    Nabiximols   Placebo (GA-0034)
STARTED   200 [1]   199 
Received at Least 1 Dose of Study Drug   198   199 
Safety Population   199 [2]   198 [3] 
ITT Population   198   199 [4] 
COMPLETED   136   158 
NOT COMPLETED   64   41 
Adverse Event                38                29 
Withdrawal by Subject                19                8 
Withdrawal by Investigator                5                3 
Lost to Follow-up                1                0 
Met Withdrawal Criteria                1                1 
[1] Two participants randomized to nabiximols did not receive any study drug
[2] One participant randomized to nabiximols received placebo Day 22 but analyzed as nabiximols-treated
[3] One participant randomized to placebo received nabiximols Day 1 but analyzed as nabiximols-treated
[4] One participant randomized to placebo received nabiximols Day 1 but analyzed as placebo-treated



  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.
All participants who were randomized in the study.

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 5 weeks. 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.
Placebo (GA-0034) Placebo 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 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
Total Total of all reporting groups

Baseline Measures
   Nabiximols   Placebo (GA-0034)   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   199   399 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (11.0)   59.6  (11.0)   59.8  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      94  47.0%      102  51.3%      196  49.1% 
Male      106  53.0%      97  48.7%      203  50.9% 


  Outcome Measures

1.  Primary:   Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

2.  Secondary:   Change From Baseline In Mean NRS Average Pain At End Of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

3.  Secondary:   Change From Baseline In Mean NRS Worst Pain At End Of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

4.  Secondary:   Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

5.  Secondary:   Subject Global Impression Of Change At Last Visit (Up To Day 36)   [ Time Frame: Last visit (up to Day 36) ]

6.  Secondary:   Physician Global Impression Of Change At Last Visit (Up To Day 36)   [ Time Frame: Last Visit (up to Day 36) ]

7.  Secondary:   Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)   [ Time Frame: Last Visit (up to Day 36) ]

8.  Secondary:   Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

9.  Secondary:   Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

10.  Secondary:   Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment   [ Time Frame: Baseline, End of Treatment (Day 36) ]

11.  Secondary:   Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)   [ Time Frame: Baseline, Last Visit (up to Day 36) ]


  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
No text entered.


  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


Publications:

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01361607     History of Changes
Other Study ID Numbers: GWCA0962
2009-016065-29 ( EudraCT Number )
First Submitted: May 25, 2011
First Posted: May 27, 2011
Results First Submitted: March 23, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018