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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01361607
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 12, 2023
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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)
Enrollment 399
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description 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 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.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Nabiximols Placebo (GA-0034) Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 200 199 399
Hide Baseline Analysis Population Description
All participants who were randomized in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 199 participants 399 participants
60.0  (11.0) 59.6  (11.0) 59.8  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 199 participants 399 participants
Female
94
  47.0%
102
  51.3%
196
  49.1%
Male
106
  53.0%
97
  48.7%
203
  50.9%
1.Primary Outcome
Title Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment
Hide Description

Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was "no pain" and 10 was "pain as bad as you can imagine". Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated).

Percentage improvement from baseline (Imp%) was calculated as:

Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean * 100.

For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew, unrelated to disease progression, before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 198 199
Median (Inter-Quartile Range)
Unit of Measure: percent improvement
7.2
(0.0 to 29.4)
9.5
(0.0 to 34.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nabiximols, Placebo (GA-0034)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2735
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-6.19 to 1.50
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline In Mean NRS Average Pain At End Of Treatment
Hide Description

Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Baseline NRS average pain score.

A negative value indicates an improvement in average pain score from Baseline.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
Nabiximols was self-administered by participants as a 100 μL oromucosal spray, up to a maximum of 10 sprays per day in the morning and evening, 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 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.
Overall Number of Participants Analyzed 198 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (1.5) -1.0  (1.5)
3.Secondary Outcome
Title Change From Baseline In Mean NRS Worst Pain At End Of Treatment
Hide Description

Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Baseline NRS worst pain score.

A negative value indicates an improvement in worst pain score from Baseline.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 198 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (1.7) -1.2  (1.6)
4.Secondary Outcome
Title Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment
Hide Description

Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Baseline sleep disruption NRS score.

A negative value indicates an improvement in sleep disruption score from Baseline.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 198 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (1.8) -1.1  (1.7)
5.Secondary Outcome
Title Subject Global Impression Of Change At Last Visit (Up To Day 36)
Hide Description The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse". The SGIC was assessed at Day 36 or at which a participant's last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.
Time Frame Last visit (up to Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 175 184
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
19
  10.9%
11
   6.0%
Much Improved
36
  20.6%
35
  19.0%
Slightly Improved
64
  36.6%
51
  27.7%
No Change
38
  21.7%
67
  36.4%
Slightly Worse
13
   7.4%
13
   7.1%
Much Worse
5
   2.9%
6
   3.3%
Very Much Worse
0
   0.0%
1
   0.5%
6.Secondary Outcome
Title Physician Global Impression Of Change At Last Visit (Up To Day 36)
Hide Description The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: "very much worse, much worse, slightly worse, no change, slightly improved, much improved, very much improved". Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.
Time Frame Last Visit (up to Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 176 184
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
13
   7.4%
11
   6.0%
Much Improved
37
  21.0%
32
  17.4%
Slightly Improved
62
  35.2%
48
  26.1%
No Change
41
  23.3%
78
  42.4%
Slightly Worse
18
  10.2%
10
   5.4%
Much Worse
5
   2.8%
4
   2.2%
Very Much Worse
0
   0.0%
1
   0.5%
7.Secondary Outcome
Title Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)
Hide Description The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.
Time Frame Last Visit (up to Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 175 184
Measure Type: Count of Participants
Unit of Measure: Participants
Extremely Satisfied
18
  10.3%
8
   4.3%
Very Satisfied
34
  19.4%
43
  23.4%
Slightly Satisfied
55
  31.4%
54
  29.3%
Neutral
35
  20.0%
52
  28.3%
Slightly Dissatisfied
13
   7.4%
15
   8.2%
Very Dissatisfied
15
   8.6%
6
   3.3%
Extremely Dissatisfied
5
   2.9%
6
   3.3%
8.Secondary Outcome
Title Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment
Hide Description

The total daily opioid use (in morphine equivalence) was the sum of morphine equivalence of daily maintenance dose and break-through dose.

Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Baseline daily total opioid use.

A negative value indicates a decrease in use from Baseline.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 198 199
Mean (Standard Deviation)
Unit of Measure: mg (morphine equivalent)
-6.5  (53.9) 2.3  (42.5)
9.Secondary Outcome
Title Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment
Hide Description

The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: "Have you used your maintenance dose painkiller today as prescribed?" If the participant answered "No" to the question, the daily opioid maintenance dose usage on that day was set to 0.

Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Baseline daily maintenance opioid dose.

A negative value indicates a decrease in dose from Baseline.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 197 199
Mean (Standard Deviation)
Unit of Measure: mg (morphine equivalent)
-1.5  (38.2) 1.9  (34.3)
10.Secondary Outcome
Title Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment
Hide Description

Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalence dose usages for each break-through opioid was calculated for the summary.

Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Baseline daily break-through opioid dose.

A negative value indicates a decrease in dose from Baseline.
Time Frame Baseline, End of Treatment (Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 198 199
Mean (Standard Deviation)
Unit of Measure: mg (morphine equivalent)
-4.4  (27.7) 0.5  (20.5)
11.Secondary Outcome
Title Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)
Hide Description

Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.

Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.

A negative value indicates improvement in condition from Baseline.
Time Frame Baseline, Last Visit (up to Day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 174 184
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (2.6) -0.6  (2.7)
Time Frame Up to Day 43 post-randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nabiximols Placebo (GA-0034)
Hide Arm/Group Description 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 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.
All-Cause Mortality
Nabiximols Placebo (GA-0034)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nabiximols Placebo (GA-0034)
Affected / at Risk (%) Affected / at Risk (%)
Total   35/199 (17.59%)   44/198 (22.22%) 
Blood and lymphatic system disorders     
Anaemia † 1  0/199 (0.00%)  1/198 (0.51%) 
Coagulopathy † 1  0/199 (0.00%)  1/198 (0.51%) 
Cardiac disorders     
Acute Myocardial Infarction † 1  0/199 (0.00%)  1/198 (0.51%) 
Cardiac Failure Congestive † 1  0/199 (0.00%)  1/198 (0.51%) 
Tachycardia † 1  1/199 (0.50%)  1/198 (0.51%) 
Gastrointestinal disorders     
Constipation † 1  2/199 (1.01%)  0/198 (0.00%) 
Vomiting † 1  1/199 (0.50%)  1/198 (0.51%) 
General disorders     
Chest Pain † 1  1/199 (0.50%)  1/198 (0.51%) 
Generalised Oedema † 1  1/199 (0.50%)  0/198 (0.00%) 
Infections and infestations     
Bronchitis † 1  0/199 (0.00%)  1/198 (0.51%) 
Device Related Infection † 1  1/199 (0.50%)  0/198 (0.00%) 
Device Related Sepsis † 1  0/199 (0.00%)  1/198 (0.51%) 
Groin Abscess † 1  0/199 (0.00%)  1/198 (0.51%) 
Helicobacter Gastritis † 1  0/199 (0.00%)  1/198 (0.51%) 
Lobar Pneumonia † 1  1/199 (0.50%)  0/198 (0.00%) 
Pneumonia † 1  1/199 (0.50%)  0/198 (0.00%) 
Pseudomembranous Colitis † 1  0/199 (0.00%)  1/198 (0.51%) 
Pyelonephritis † 1  0/199 (0.00%)  1/198 (0.51%) 
Staphylococcal Sepsis † 1  0/199 (0.00%)  1/198 (0.51%) 
Urinary Tract Infection † 1  1/199 (0.50%)  0/198 (0.00%) 
Injury, poisoning and procedural complications     
Fall † 1  1/199 (0.50%)  0/198 (0.00%) 
Post Procedural Haemorrhage † 1  0/199 (0.00%)  1/198 (0.51%) 
Wound Haemorrhage † 1  0/199 (0.00%)  1/198 (0.51%) 
Metabolism and nutrition disorders     
Cachexia † 1  1/199 (0.50%)  0/198 (0.00%) 
Dehydration † 1  1/199 (0.50%)  1/198 (0.51%) 
Hypoalbuminaemia † 1  1/199 (0.50%)  0/198 (0.00%) 
Hypoglycaemia † 1  0/199 (0.00%)  1/198 (0.51%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer Pain † 1  0/199 (0.00%)  1/198 (0.51%) 
Chondrosarcoma Metastatic † 1  1/199 (0.50%)  0/198 (0.00%) 
Colorectal Cancer † 1  1/199 (0.50%)  0/198 (0.00%) 
Meningioma Malignant † 1  0/199 (0.00%)  1/198 (0.51%) 
Neoplasm Progression † 1  23/199 (11.56%)  31/198 (15.66%) 
Nervous system disorders     
Cerebrovascular Accident † 1  1/199 (0.50%)  0/198 (0.00%) 
Convulsion † 1  0/199 (0.00%)  1/198 (0.51%) 
Somnolence † 1  1/199 (0.50%)  0/198 (0.00%) 
Psychiatric disorders     
Anxiety † 1  1/199 (0.50%)  0/198 (0.00%) 
Disorientation † 1  1/199 (0.50%)  0/198 (0.00%) 
Renal and urinary disorders     
Hydronephrosis † 1  0/199 (0.00%)  1/198 (0.51%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  1/199 (0.50%)  0/198 (0.00%) 
Pleural Effusion † 1  1/199 (0.50%)  0/198 (0.00%) 
Vascular disorders     
Hypotension † 1  1/199 (0.50%)  0/198 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nabiximols Placebo (GA-0034)
Affected / at Risk (%) Affected / at Risk (%)
Total   59/199 (29.65%)   45/198 (22.73%) 
Gastrointestinal disorders     
Constipation † 1  8/199 (4.02%)  13/198 (6.57%) 
Nausea † 1  19/199 (9.55%)  16/198 (8.08%) 
Vomiting † 1  17/199 (8.54%)  13/198 (6.57%) 
Nervous system disorders     
Dizziness † 1  16/199 (8.04%)  9/198 (4.55%) 
Somnolence † 1  23/199 (11.56%)  8/198 (4.04%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[Not Specified]
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.
Results Point of Contact
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Name/Title: Medical Enquiries
Organization: GW Pharmaceuticals Ltd.
EMail: medinfo.USA@gwpharm.com
Publications:
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01361607    
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 12, 2023