Cancer, Pain, Palliative Care
Conditions
Keywords
Palliative Care, Pain, Cancer
Brief summary
The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
Detailed description
This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).
Interventions
DRUGPlacebo
Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.
DRUGSativex®
Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.
DRUGTHC Alone
Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
Sponsors
Jazz Pharmaceuticals
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
* Willing and able to give informed consent. * Male or female, age 18 years or above. * Diagnosed with cancer of any type, which is considered to be terminal. * Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose level of pain measured on a NRS is ³four on at least one occasion per day, during the two day run-in period, leading up to visit 1. * On strong opioid maintenance therapy for at least seven days prior to the screening visit. * Willing to abstain from any use of cannabis during the study, other than the study medication. * No cannabinoids use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabis during the study. * Clinically acceptable blood results at the screening visit. * Able (in the investigators opinion) and willing to undertake and comply with all study requirements. * Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation. * Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).
Exclusion criteria
* Know history of substance misuse. * Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness. * Received any epidural analgesia within 48 hours prior to study entry. * Either received, within two weeks of study entry, or due to receive chemotherapy or radiotherapy during the study. * Unable to give informed consent. * History of any type of schizophrenia, any other psychotic illness, a serious personality disorder, or other significant psychiatric illness other than depression associated with their chronic pain and/or in response to the underlying condition. * Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®). * Had a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia. * Significant renal or hepatic impairment, who in the opinion of the investigator, were unsuitable for treatment with study medication. * History of epilepsy. * Had oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth. * Female subjects who were pregnant or lactating or of child-bearing potential and were inadequately protected against conception during the study and for three months thereafter. * Male subjects who were sexually active and who were not using adequate forms of contraception during the study and for three months thereafter. * Subjects who had participated in a clinical research study in the past four weeks, prior to study entry. * Planned travel outside the UK during the study (applicable to the UK centres only). * Subjects who, in the opinion of the investigator, were unsuitable to participate in the study for any other reason, not mentioned in the entry criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. | 2 weeks: baseline - end of week 2 (last 3 days of treatment) | The 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. |
| The Consumption of Escape Analgesic Medication. | 2 weeks: baseline - end of week 2 (last 3 days of treatment) | Subjects recorded their use of escape medication each day on their diary card. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory 0-10 Numerical Rating Scale | 2 weeks: baseline - end of week 2 (last 3 days of treatment) | The memory 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 well you are able to remember what you have done in the past 24 hours? where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline. |
| Appetite 0-10 Numerical Rating Scale | 2 weeks: baseline - end of week 2 (last 3 days of treatment) | The appetite 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 appetite has been throughout the day? where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline. |
| Sleep Disturbance 0-10 Numerical Rating Scale | 2 weeks: baseline to end of week 2 (last 3 days of treatment) | 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. |
| EORTC Quality of Life Questionnaire (EORTC-QLQC30) | 2 weeks; baseline and end of treatment (2 weeks) | Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100 |
| Brief Pain Inventory Short Form | End of 2 weeks | 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. |
| Concentration 0-10 Numerical Rating Scale | 2 weeks: baseline - end of week 2 (last 3 days of treatment) | The concentration 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 well have you been able to concentrate throughout the day e.g. when reading a newspaper? where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline. |
| Nausea 0-10 Numerical Rating Scale | 2 weeks; baseline - end of week 2 (last 3 days of treatment) | The nausea 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 sick you felt throughout the day? where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sativex Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD | 60 |
| THC Alone Each 100 uL actuation contained 27 mg/ml THC | 58 |
| Placebo Each 100 uL actuation contained colourant and excipients | 59 |
| Total | 177 |
Baseline characteristics
| Characteristic | Sativex | THC Alone | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 20 Participants | 21 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 38 Participants | 38 Participants | 115 Participants |
| Age, Continuous | 59.4 years STANDARD_DEVIATION 12.08 | 61.3 years STANDARD_DEVIATION 12.5 | 60.1 years STANDARD_DEVIATION 12.31 | 60.2 years STANDARD_DEVIATION 12.25 |
| Region of Enrollment Belgium | 4 participants | 4 participants | 3 participants | 11 participants |
| Region of Enrollment Romania | 34 participants | 36 participants | 35 participants | 105 participants |
| Region of Enrollment United Kingdom | 22 participants | 18 participants | 21 participants | 61 participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 27 Participants | 82 Participants |
| Sex: Female, Male Male | 33 Participants | 30 Participants | 32 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 60 | 45 / 58 | 44 / 59 |
| serious Total, serious adverse events | 13 / 60 | 13 / 58 | 7 / 59 |
Outcome results
Primary
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
The 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: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. | -1.32 units on a scale | Standard Deviation 1.64 |
| THC Alone | The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. | -0.93 units on a scale | Standard Deviation 1.15 |
| Placebo | The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. | -0.73 units on a scale | Standard Deviation 1.51 |
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. The null hypothesis was that of no treatment difference.p-value: 0.01495% CI: [-1.21, -0.14]ANCOVA
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. The null hypothesis was that of no treatment difference.p-value: 0.24495% CI: [-0.86, 0.22]ANCOVA
Primary
The Consumption of Escape Analgesic Medication.
Subjects recorded their use of escape medication each day on their diary card.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Population: The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | The Consumption of Escape Analgesic Medication. | 0.72 tablets per day | Standard Deviation 0.821 |
| THC Alone | The Consumption of Escape Analgesic Medication. | 0.88 tablets per day | Standard Deviation 0.852 |
| Placebo | The Consumption of Escape Analgesic Medication. | 0.68 tablets per day | Standard Deviation 0.662 |
Comparison: The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.p-value: 0.68895% CI: [-0.25, 0.16]Regression, Logistic
Comparison: The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.p-value: 0.89995% CI: [-0.19, 0.22]Regression, Logistic
Secondary
Appetite 0-10 Numerical Rating Scale
The appetite 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 appetite has been throughout the day? where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Appetite 0-10 Numerical Rating Scale | 0.24 units on a scale | Standard Deviation 2.29 |
| THC Alone | Appetite 0-10 Numerical Rating Scale | 0.18 units on a scale | Standard Deviation 1.91 |
| Placebo | Appetite 0-10 Numerical Rating Scale | -1.65 units on a scale | Standard Deviation 1.94 |
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.01695% CI: [0.16, 1.51]ANCOVA
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.05695% CI: [-0.02, 1.33]ANCOVA
Secondary
Brief Pain Inventory Short Form
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: End of 2 weeks
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Brief Pain Inventory Short Form | 0.2 units on a scale | Standard Deviation 5.63 |
| THC Alone | Brief Pain Inventory Short Form | -3.38 units on a scale | Standard Deviation 6.43 |
| Placebo | Brief Pain Inventory Short Form | 0.41 units on a scale | Standard Deviation 5.55 |
Comparison: Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.p-value: 0.61995% CI: [-5.23, 3.15]ANCOVA
Comparison: Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.p-value: 0.04895% CI: [-8.1, -0.05]ANCOVA
Secondary
Concentration 0-10 Numerical Rating Scale
The concentration 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 well have you been able to concentrate throughout the day e.g. when reading a newspaper? where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Concentration 0-10 Numerical Rating Scale | 0.26 units on a scale | Standard Deviation 1.66 |
| THC Alone | Concentration 0-10 Numerical Rating Scale | 0.22 units on a scale | Standard Deviation 1.8 |
| Placebo | Concentration 0-10 Numerical Rating Scale | -0.32 units on a scale | Standard Deviation 1.39 |
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.02195% CI: [0.1, 1.25]ANCOVA
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.02895% CI: [0.07, 1.22]ANCOVA
Secondary
EORTC Quality of Life Questionnaire (EORTC-QLQC30)
Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
Time frame: 2 weeks; baseline and end of treatment (2 weeks)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | EORTC Quality of Life Questionnaire (EORTC-QLQC30) | 4.93 units on a scale | Standard Deviation 17.51 |
| THC Alone | EORTC Quality of Life Questionnaire (EORTC-QLQC30) | 3.57 units on a scale | Standard Deviation 18.32 |
| Placebo | EORTC Quality of Life Questionnaire (EORTC-QLQC30) | 4.74 units on a scale | Standard Deviation 18.5 |
Comparison: Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.p-value: 0.44395% CI: [-3.87, 8.81]ANCOVA
Comparison: Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.p-value: 0.79395% CI: [-5.46, 7.13]ANCOVA
Secondary
Memory 0-10 Numerical Rating Scale
The memory 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 well you are able to remember what you have done in the past 24 hours? where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Memory 0-10 Numerical Rating Scale | 0.58 units on a scale | Standard Deviation 2.06 |
| THC Alone | Memory 0-10 Numerical Rating Scale | 0.57 units on a scale | Standard Deviation 1.9 |
| Placebo | Memory 0-10 Numerical Rating Scale | 0 units on a scale | Standard Deviation 1.35 |
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.04595% CI: [0.01, 1.28]ANCOVA
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.05395% CI: [-0.01, 1.25]ANCOVA
Secondary
Nausea 0-10 Numerical Rating Scale
The nausea 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 sick you felt throughout the day? where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
Time frame: 2 weeks; baseline - end of week 2 (last 3 days of treatment)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Nausea 0-10 Numerical Rating Scale | 0 units on a scale | Standard Deviation 2.19 |
| THC Alone | Nausea 0-10 Numerical Rating Scale | 0.27 units on a scale | Standard Deviation 1.83 |
| Placebo | Nausea 0-10 Numerical Rating Scale | -0.16 units on a scale | Standard Deviation 1.25 |
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.1195% CI: [-0.11, 1.09]ANCOVA
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.12695% CI: [-0.13, 1.05]ANCOVA
Secondary
Sleep Disturbance 0-10 Numerical Rating Scale
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: 2 weeks: baseline to end of week 2 (last 3 days of treatment)
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Sleep Disturbance 0-10 Numerical Rating Scale | -0.59 units on a scale | Standard Deviation 1.88 |
| THC Alone | Sleep Disturbance 0-10 Numerical Rating Scale | -0.25 units on a scale | Standard Deviation 2.33 |
| Placebo | Sleep Disturbance 0-10 Numerical Rating Scale | -0.21 units on a scale | Standard Deviation 1.72 |
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.34695% CI: [-0.97, 0.34]ANCOVA
Comparison: Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.p-value: 0.9595% CI: [-0.64, 0.68]ANCOVA