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A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01424566
Recruitment Status : Completed
First Posted : August 29, 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. Participants were included and analyzed according to the treatment group they were randomized to.

Reporting Groups
  Description
Single-blind 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 2 weeks. 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 flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Double-blind Nabiximols Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in Numerical Rating Scale (NRS) pain scores during the single-blind treatment period (Part A).
Double-blind Placebo (GA-0034) Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).

Participant Flow for 2 periods

Period 1:   Single-blind Treatment
    Single-blind Nabiximols   Double-blind Nabiximols   Double-blind Placebo (GA-0034)
STARTED   406   0 [1]   0 [1] 
Received at Least 1 Dose of Study Drug   404 [2]   0   0 
Single-blind Safety Population   404   0   0 
Met Randomization Criteria   206   0   0 
COMPLETED   206   0   0 
NOT COMPLETED   200   0   0 
Adverse Event                71                0                0 
Withdrawal by Subject                16                0                0 
Withdrawal by Investigator                2                0                0 
Did Not Meet Inclusion Criteria                108                0                0 
Met Exclusion Criteria                1                0                0 
Did Not Administer Any Study Drug                2                0                0 
[1] Participants were not enrolled in this arm in the single-blind period.
[2] Two participants did not administer any study drug.

Period 2:   Double-blind Treatment
    Single-blind Nabiximols   Double-blind Nabiximols   Double-blind Placebo (GA-0034)
STARTED   0 [1]   103 [2]   103 [2] 
Received at Least 1 Dose of Study Drug   0   103   103 
Randomized Safety Population   0   103   103 
ITT Population   0   103   103 
COMPLETED   0   78   88 
NOT COMPLETED   0   25   15 
Adverse Event                0                21                13 
Withdrawal by Subject                0                2                0 
Withdrawal by Investigator                0                1                1 
Lack of Efficacy                0                1                1 
[1] Participants were not enrolled in this arm in the double-blind period.
[2] Participants were not enrolled in this arm in the single-blind period.



  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 and received at least 1 dose of study drug. Two participants who were randomized in the single-blind treatment period did not administer any study drug.

Reporting Groups
  Description
Single-blind 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 2 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.

Baseline Measures
   Single-blind Nabiximols 
Overall Participants Analyzed 
[Units: Participants]
 406 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      177  43.6% 
Male      229  56.4% 


  Outcome Measures

1.  Primary:   Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment   [ Time Frame: Randomization Baseline, End of Treatment (Day 36 of the double-blind period) ]

2.  Secondary:   Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment   [ Time Frame: Eligibility Baseline, End of Treatment (Day 36 of the double-blind period) ]

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

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

5.  Secondary:   Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period)   [ Time Frame: Last Visit (up to Day 36 of the double-blind period) ]

6.  Secondary:   Physician Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period)   [ Time Frame: Last Visit (up to Day 36 of the double-blind period) ]

7.  Secondary:   Patient Satisfaction Questionnaire At Last Visit (Up To Day 36 Of The Double-blind Period)   [ Time Frame: Last Visit (up to Day 36 of the double-blind period) ]

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

9.  Secondary:   Change From Randomization Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End Of Treatment   [ Time Frame: Randomization Baseline, End of Treatment (Day 36 of the double-blind period) ]

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

11.  Secondary:   Change From Randomization Baseline In NRS Constipation At Last Visit (Up To Day 36 Of The Double-blind Period)   [ Time Frame: Randomization Baseline, Last Visit (up to Day 36 of the double-blind period) ]


  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: NCT01424566     History of Changes
Other Study ID Numbers: GWCA1103
2010-022905-17 ( EudraCT Number )
First Submitted: August 25, 2011
First Posted: August 29, 2011
Results First Submitted: March 23, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018