Cancer, Pain, Palliative Care
Conditions
Keywords
Pain, Cancer, Palliative
Brief summary
The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.
Interventions
DRUGSativex Low Dose
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
DRUGSativex Medium Dose
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
DRUGSativex High Dose
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Sponsors
Quintiles, Inc.
GW Pharmaceuticals Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has advanced active cancer for which there is no known curative therapy. * The patient is able (in the investigators opinion) and willing to comply with all study requirements. * The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment. * The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder. * The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.
Exclusion criteria
* The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. * Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. * Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug. * The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure). * The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline | 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days) | A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily NRS Pain Score (Average Pain). | 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5) | The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline. |
| Change in Mean Daily NRS Pain Score (Worst Pain). | 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5) | The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline. |
| Change in Sleep Disruption NRS | 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5) | The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline. |
| Change in Cumulative Average Pain Response Curves | Baseline to end of treatment (Week 5) | The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response. The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. |
| Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) | Baseline (Visit 2) and End of Treatment (Week 5 or premature termination) | The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement. |
| Change in Patient Global Impression of Change - PGIC | End of Week 5 | A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to cancer since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported. |
| Change in Montgomery Asberg Depression Rating Scale (MADRS) | Baseline and End of Treatment (Week 5 or premature termination) | The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression. |
| Change in Brief Pain Inventory - Short Form (BPI-SF) | Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination) | The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome. |
Countries
Belgium, Canada, Chile, Czechia, Finland, France, Germany, India, Italy, Mexico, Poland, Romania, South Africa, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sativex High Dose Group Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD. | 90 |
| Sativex Medium Dose Group Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD. | 88 |
| Sativex Low Dose Group Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD. | 91 |
| Placebo Range of 1-16 sprays per day of placebo spray | 91 |
| Total | 360 |
Baseline characteristics
| Characteristic | Sativex High Dose Group | Sativex Medium Dose Group | Sativex Low Dose Group | Placebo | Total |
|---|---|---|---|---|---|
| Age Continuous | 58 years STANDARD_DEVIATION 11.2 | 59 years STANDARD_DEVIATION 31.1 | 59 years STANDARD_DEVIATION 12.3 | 56 years STANDARD_DEVIATION 12.2 | 58 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 42 Participants | 39 Participants | 46 Participants | 47 Participants | 174 Participants |
| Sex: Female, Male Male | 48 Participants | 49 Participants | 45 Participants | 44 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 82 / 90 | 73 / 87 | 68 / 91 | 69 / 91 |
| serious Total, serious adverse events | 28 / 90 | 18 / 87 | 35 / 91 | 23 / 91 |
Outcome results
Primary
Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.
Time frame: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sativex High Dose Group | Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline | 22 Participants |
| Sativex Medium Dose Group | Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline | 26 Participants |
| Sativex Low Dose Group | Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline | 30 Participants |
| Placebo | Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline | 24 Participants |
Comparison: The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.p-value: 0.3395% CI: [0.72, 2.6]Regression, Logistic
Comparison: As for Sativex Low dose versus placebop-value: 0.6295% CI: [0.46, 1.76]Regression, Logistic
Comparison: As for Sativex Low dose versus placebop-value: 0.6195% CI: [0.62, 2.28]Regression, Logistic
Secondary
Change in Brief Pain Inventory - Short Form (BPI-SF)
The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome.
Time frame: Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex High Dose Group | Change in Brief Pain Inventory - Short Form (BPI-SF) | -1.0 Score on scale | Standard Deviation 1.9 |
| Sativex Medium Dose Group | Change in Brief Pain Inventory - Short Form (BPI-SF) | -1.5 Score on scale | Standard Deviation 1.6 |
| Sativex Low Dose Group | Change in Brief Pain Inventory - Short Form (BPI-SF) | -1.3 Score on scale | Standard Deviation 2.3 |
| Placebo | Change in Brief Pain Inventory - Short Form (BPI-SF) | -1.0 Score on scale | Standard Deviation 1.9 |
Secondary
Change in Cumulative Average Pain Response Curves
The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response. The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer.
Time frame: Baseline to end of treatment (Week 5)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sativex High Dose Group | Change in Cumulative Average Pain Response Curves | -13 Percent Change |
| Sativex Medium Dose Group | Change in Cumulative Average Pain Response Curves | -20 Percent Change |
| Sativex Low Dose Group | Change in Cumulative Average Pain Response Curves | -20 Percent Change |
| Placebo | Change in Cumulative Average Pain Response Curves | -10 Percent Change |
Comparison: Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.p-value: 0.007795% CI: [-21.35, -3.33]Wilcoxon rank sum tests
Comparison: As for Sativex low dose versus placebop-value: 0.6795% CI: [-11.04, 7.14]Wilcoxin rank sum test
Comparison: As for Sativex low dose versus placebop-value: 0.03995% CI: [-17.14, 0]Wilcoxin rank sum test
Secondary
Change in Mean Daily NRS Pain Score (Average Pain).
The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Time frame: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex High Dose Group | Change in Mean Daily NRS Pain Score (Average Pain). | -0.9 Points on scale | Standard Deviation 1.9 |
| Sativex Medium Dose Group | Change in Mean Daily NRS Pain Score (Average Pain). | -1.2 Points on scale | Standard Deviation 1.7 |
| Sativex Low Dose Group | Change in Mean Daily NRS Pain Score (Average Pain). | -1.6 Points on scale | Standard Deviation 2.1 |
| Placebo | Change in Mean Daily NRS Pain Score (Average Pain). | -0.8 Points on scale | Standard Deviation 1.8 |
Comparison: The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.p-value: 0.00695% CI: [-1.28, -0.22]ANCOVA
Comparison: As for Sativex low dose versus placebop-value: 0.7595% CI: [-0.62, 0.44]ANCOVA
Comparison: As for Sativex low dose versus placebop-value: 0.1995% CI: [-0.89, 0.18]ANCOVA
Secondary
Change in Mean Daily NRS Pain Score (Worst Pain).
The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline.
Time frame: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex High Dose Group | Change in Mean Daily NRS Pain Score (Worst Pain). | -1.0 Points on scale | Standard Deviation 1.9 |
| Sativex Medium Dose Group | Change in Mean Daily NRS Pain Score (Worst Pain). | -1.2 Points on scale | Standard Deviation 1.8 |
| Sativex Low Dose Group | Change in Mean Daily NRS Pain Score (Worst Pain). | -1.6 Points on scale | Standard Deviation 2.2 |
| Placebo | Change in Mean Daily NRS Pain Score (Worst Pain). | -0.9 Points on scale | Standard Deviation 2 |
Comparison: The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.p-value: 0.01195% CI: [-1.3, -0.17]ANCOVA
Comparison: As for Sativex low dose versus placebop-value: 0.1495% CI: [-0.81, 0.11]ANCOVA
Comparison: As for Sativex low dose versus placebop-value: 0.495% CI: [-0.81, 0.32]ANCOVA
Secondary
Change in Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.
Time frame: Baseline and End of Treatment (Week 5 or premature termination)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex High Dose Group | Change in Montgomery Asberg Depression Rating Scale (MADRS) | -0.4 Score on scale | Standard Deviation 8.6 |
| Sativex Medium Dose Group | Change in Montgomery Asberg Depression Rating Scale (MADRS) | -1.0 Score on scale | Standard Deviation 8.5 |
| Sativex Low Dose Group | Change in Montgomery Asberg Depression Rating Scale (MADRS) | -1.1 Score on scale | Standard Deviation 7 |
| Placebo | Change in Montgomery Asberg Depression Rating Scale (MADRS) | -2.9 Score on scale | Standard Deviation 9 |
Secondary
Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)
The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.
Time frame: Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex High Dose Group | Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) | 0.0 Score on scale | Standard Deviation 0.7 |
| Sativex Medium Dose Group | Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) | -0.1 Score on scale | Standard Deviation 0.5 |
| Sativex Low Dose Group | Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) | 0.0 Score on scale | Standard Deviation 0.6 |
| Placebo | Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) | -0.1 Score on scale | Standard Deviation 0.6 |
Secondary
Change in Patient Global Impression of Change - PGIC
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to cancer since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Time frame: End of Week 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | Slightly worse | 6 Participants |
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | Very much worse | 2 Participants |
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | Very much improved | 6 Participants |
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | Slightly improved | 25 Participants |
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | Much improved | 20 Participants |
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | Much worse | 1 Participants |
| Sativex High Dose Group | Change in Patient Global Impression of Change - PGIC | No change | 13 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | Very much improved | 6 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | No change | 13 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | Very much worse | 2 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | Slightly worse | 5 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | Much improved | 19 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | Much worse | 0 Participants |
| Sativex Medium Dose Group | Change in Patient Global Impression of Change - PGIC | Slightly improved | 26 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | Slightly worse | 3 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | Much worse | 1 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | Much improved | 24 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | Slightly improved | 19 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | No change | 13 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | Very much improved | 10 Participants |
| Sativex Low Dose Group | Change in Patient Global Impression of Change - PGIC | Very much worse | 0 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | Very much worse | 0 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | Very much improved | 9 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | Much improved | 16 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | Slightly improved | 28 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | No change | 17 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | Slightly worse | 1 Participants |
| Placebo | Change in Patient Global Impression of Change - PGIC | Much worse | 1 Participants |
Secondary
Change in Sleep Disruption NRS
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Time frame: 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex High Dose Group | Change in Sleep Disruption NRS | -0.7 Points on scale | Standard Deviation 2.1 |
| Sativex Medium Dose Group | Change in Sleep Disruption NRS | -0.9 Points on scale | Standard Deviation 2.1 |
| Sativex Low Dose Group | Change in Sleep Disruption NRS | -1.5 Points on scale | Standard Deviation 2.1 |
| Placebo | Change in Sleep Disruption NRS | -0.8 Points on scale | Standard Deviation 2.2 |
Comparison: The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.p-value: 0.00395% CI: [-1.45, -0.31]ANCOVA
Comparison: As for Sativex low dose versus placebop-value: 0.7895% CI: [-0.65, 0.49]ANCOVA
Comparison: As for Sativex low dose versus placebo.p-value: 0.2695% CI: [-0.9, 0.24]ANCOVA