18 and older, any sex, with Pain or Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Improvement From Baseline In Mean NRS Average Pain At End Of TreatmentPrimary· Baseline, End of Treatment (Day 36)
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 Treat
Group
Value
95% CI
Nabiximols
7.2
0.0 – 29.4
Placebo (GA-0034)
9.5
0.0 – 34.5
Change From Baseline In Mean NRS Average Pain At End Of TreatmentSecondary· Baseline, End of Treatment (Day 36)
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.
Group
Value
95% CI
Nabiximols
-0.9
± 1.5
Placebo (GA-0034)
-1.0
± 1.5
Change From Baseline In Mean NRS Worst Pain At End Of TreatmentSecondary· Baseline, End of Treatment (Day 36)
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.
Group
Value
95% CI
Nabiximols
-1.0
± 1.7
Placebo (GA-0034)
-1.2
± 1.6
Change From Baseline In Mean Sleep Disruption NRS At End Of TreatmentSecondary· Baseline, End of Treatment (Day 36)
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.
Group
Value
95% CI
Nabiximols
-0.9
± 1.8
Placebo (GA-0034)
-1.1
± 1.7
Subject Global Impression Of Change At Last Visit (Up To Day 36)Secondary· Last visit (up to Day 36)
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.
Group
Value
95% CI
Nabiximols
19
Placebo (GA-0034)
11
Nabiximols
36
Placebo (GA-0034)
35
Nabiximols
64
Placebo (GA-0034)
51
Nabiximols
38
Placebo (GA-0034)
67
Physician Global Impression Of Change At Last Visit (Up To Day 36)Secondary· Last Visit (up to Day 36)
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.
Group
Value
95% CI
Nabiximols
13
Placebo (GA-0034)
11
Nabiximols
37
Placebo (GA-0034)
32
Nabiximols
62
Placebo (GA-0034)
48
Nabiximols
41
Placebo (GA-0034)
78
Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)Secondary· Last Visit (up to Day 36)
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.
Group
Value
95% CI
Nabiximols
18
Placebo (GA-0034)
8
Nabiximols
34
Placebo (GA-0034)
43
Nabiximols
55
Placebo (GA-0034)
54
Nabiximols
35
Placebo (GA-0034)
52
Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of TreatmentSecondary· Baseline, End of Treatment (Day 36)
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.
Group
Value
95% CI
Nabiximols
-6.5
± 53.9
Placebo (GA-0034)
2.3
± 42.5
Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of TreatmentSecondary· Baseline, End of Treatment (Day 36)
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.
Group
Value
95% CI
Nabiximols
-1.5
± 38.2
Placebo (GA-0034)
1.9
± 34.3
Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of TreatmentSecondary· Baseline, End of Treatment (Day 36)
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.
Group
Value
95% CI
Nabiximols
-4.4
± 27.7
Placebo (GA-0034)
0.5
± 20.5
Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)Secondary· Baseline, Last Visit (up to Day 36)
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.
Group
Value
95% CI
Nabiximols
-0.4
± 2.6
Placebo (GA-0034)
-0.6
± 2.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 43 post-randomization.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nabiximols
Serious: 35/199 (18%)
Deaths: —
Placebo (GA-0034)
Serious: 44/198 (22%)
Deaths: —
Serious adverse events (41 terms)
Reaction
System
Nabiximols
Placebo (GA-0034)
Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer.
Eligible participants were not required to stop any of their current treatments or medications.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05974293 — A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders
· Phase 2
· withdrawn
NCT04984278 — Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple
· Phase 3
· terminated
NCT04657666 — Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Mult
· Phase 3
· completed
NCT04203498 — Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multipl
· Phase 3
· terminated
NCT01424566 — A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cance
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
Last refreshed: 12 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01361607.