Pain
Conditions
Brief summary
A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with placebo in the treatment of chronic pain due to brachial plexus injury.
Detailed description
This study used a three way crossover study design. Eligible patients recorded their symptoms during a one to two week baseline period, then entered a three period, double blind, randomised crossover of GW-1000-02, GW-2000-02 and placebo. Each period lasted two weeks, with no washout between periods. There were six possible treatment sequences. The primary analysis was based on Box Scale-11 pain severity scores recorded throughout the study in patient daily diary booklets. Blood samples were taken from patient-volunteers at the beginning of each period, for measurement of plasma cannabinoid concentration.
Interventions
DRUGGW-1000-02
Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.
DRUGGW-2000-02
Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day.
DRUGPlacebo
Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or above. * Brachial plexus pain, at least 18 months after the initial injury. * Reported weekly brachial plexus pain at the required severity at Visits 1 and 2; a Box Scale-11 pain severity score of four boxes or above. * A pattern of pain that in the Investigator's opinion had been stable during the four weeks before study entry. * Stable regular medication during the four weeks before study entry. * A maximum tricyclic antidepressant dose of 75 mg per day, if applicable. * No cannabinoid use (cannabis, Marinol® or Nabilone) at least seven days before study entry or during the study. * If sexually active; was either using effective contraception during the study and for three months thereafter or had been surgically sterilised or, if female, was post-menopausal. All patients agreed to use a barrier method of contraception in addition to their usual form of oral or depot contraception. * Willing and able to undertake and comply with all study requirements. * Willing and able to consider and understand the patient information leaflet and consent form and to give informed consent. Those patients unable to read or to sign the document were managed as detailed in the Declaration of Helsinki. * Willing for his or her general practitioner, and consultant if appropriate, to be informed of study participation. * Willing for his or her name to be notified to Home Office for participation in the study.
Exclusion criteria
* Abuse or strong suspicion of drug abuse, including alcohol or cannabis, or in the investigator's opinion had a tendency to drug dependency or substance abuse. Patients with a history of abuse could have been included at the discretion of the investigator. * Known or suspected adverse reaction to cannabinoids. * Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication. * History of any type of schizophrenia, any other psychotic illness, or other significant psychiatric illness other than depression associated with chronic illness. * Regular levodopa therapy (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®) within seven days of study entry. * Serious cardiovascular disorder including recent angina, uncontrolled hypertension or an uncontrolled symptomatic cardiac arrhythmia. * History of significant renal or hepatic impairment as shown in medical history or indicated by clinical laboratory results from samples. * History of active epilepsy or convulsions. * Nerve surgery within six months of study entry or any other surgery within two months of study entry. * Elective surgery, other procedures requiring general anaesthesia, or a planned hospital admission that would have taken place during the study, other than a hospital admission under the care of the study investigator. * Terminal illness. * Pregnancy, lactation or expected non-compliance with the contraceptive measures called for by the protocol. * Participation in any other pharmacological clinical research study in the 12 weeks before study entry. * Planned travel outside the UK between study entry and the end of the crossover phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days) | Up to 74 days | Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero no pain at all to 10 pain as bad as you can imagine. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Up to 74 days | Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero Worst Imaginable to 10 Best Imaginable. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline. |
| Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Up to 74 days | Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = None, one = Mild, two = Moderate and three = Severe. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline. |
| Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Up to 74 days | Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero No pain to 100 Worst possible pain. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline. |
| Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Up to 74 days | Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as None, Once, Twice and More Than Twice and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline. |
| Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Up to 74 days | The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with no disability and 10 equated with total disability. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline. |
| Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Up to 74 days | The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline. |
| Incidence of Adverse Events as a Measure of Patient Safety. | Up to 114 days | The number of patients who experienced an adverse event during the course of study is presented. |
| Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Up to 74 days | Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as No Pain, Mild, Discomforting, Distressing, Horrible and Excruciating. The change from baseline in the number of patients who reported No Pain or Mild Pain at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Treatments: GW-1000-02, GW-2000-02 and Placebo As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Second Intenvention (14-20 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Third Intenvention (14-20 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Treatments: GW-1000-02, GW-2000-02 and Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous | 38.53 years STANDARD_DEVIATION 10.342 |
| Region of Enrollment United Kingdom | 48 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 46 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 | 34 / 46 | 37 / 47 | 20 / 48 |
| serious Total, serious adverse events | 1 / 46 | 0 / 47 | 0 / 48 |
Outcome results
Primary
Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)
Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero no pain at all to 10 pain as bad as you can imagine. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days) | -0.6 units on a scale | Standard Deviation 1.13 |
| GW-2000-02 | Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days) | -0.6 units on a scale | Standard Deviation 1.34 |
| Placebo | Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days) | 0.0 units on a scale | Standard Deviation 1.23 |
Comparison: Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Periodp-value: 0.00595% CI: [-0.98, -0.18]ANOVA
Comparison: Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Periodp-value: 0.00295% CI: [-1.03, -0.24]ANOVA
Secondary
Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -2.2 units on a scale | Standard Deviation 6.7 |
| GW-2000-02 | Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -1.2 units on a scale | Standard Deviation 6.12 |
| Placebo | Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | 0.1 units on a scale | Standard Deviation 3.92 |
Comparison: 12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Periodp-value: 0.01595% CI: [-4.01, -0.45]ANOVA
Comparison: 12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Periodp-value: 0.17895% CI: [-2.97, 0.56]ANOVA
Secondary
Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero Worst Imaginable to 10 Best Imaginable. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | 0.9 units on a scale | Standard Deviation 1.22 |
| GW-2000-02 | Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | 1.2 units on a scale | Standard Deviation 1.39 |
| Placebo | Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | 0.4 units on a scale | Standard Deviation 1.4 |
Comparison: Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Periodp-value: 0.01995% CI: [0.09, 1.01]ANOVA
Comparison: Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Periodp-value: 0.00195% CI: [0.33, 1.24]ANOVA
Secondary
Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)
Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = None, one = Mild, two = Moderate and three = Severe. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days) | -3.2 units on a scale | Standard Deviation 8.91 |
| GW-2000-02 | Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days) | -3.8 units on a scale | Standard Deviation 9.37 |
| Placebo | Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days) | -1.8 units on a scale | Standard Deviation 9.26 |
Comparison: Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Periodp-value: 0.14695% CI: [-3.64, 0.55]ANOVA
Comparison: Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Periodp-value: 0.0495% CI: [-4.29, -0.1]ANOVA
Secondary
Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)
Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero No pain to 100 Worst possible pain. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days) | -14.9 units on a scale | Standard Deviation 25.15 |
| GW-2000-02 | Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days) | -17.3 units on a scale | Standard Deviation 26.74 |
| Placebo | Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days) | -8.0 units on a scale | Standard Deviation 26.92 |
Comparison: Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Periodp-value: 0.09295% CI: [-15.78, 1.21]ANOVA
Comparison: Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Periodp-value: 0.03795% CI: [-17.41, -0.57]ANOVA
Secondary
Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with no disability and 10 equated with total disability. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -5.3 units on a scale | Standard Deviation 9.97 |
| GW-2000-02 | Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -3.1 units on a scale | Standard Deviation 10.37 |
| Placebo | Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -3.6 units on a scale | Standard Deviation 7.69 |
Comparison: Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Periodp-value: 0.18195% CI: [-4.32, 0.83]ANOVA
Comparison: Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Periodp-value: 0.73995% CI: [-2.12, 2.98]ANOVA
Secondary
Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as None, Once, Twice and More Than Twice and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GW-1000-02 | Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -0.2 units on a scale | Standard Deviation 0.43 |
| GW-2000-02 | Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | -0.4 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | 0.0 units on a scale | Standard Deviation 0.47 |
Comparison: Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Periodp-value: 0.01795% CI: [-0.37, -0.04]ANOVA
Comparison: Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Periodp-value: <0.00195% CI: [-0.49, -0.16]ANOVA
Secondary
Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)
Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as No Pain, Mild, Discomforting, Distressing, Horrible and Excruciating. The change from baseline in the number of patients who reported No Pain or Mild Pain at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.
Time frame: Up to 74 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GW-1000-02 | Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days) | 4 participants |
| GW-2000-02 | Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days) | 4 participants |
| Placebo | Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days) | 3 participants |
Comparison: Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.p-value: 0.328Wilcoxon (Mann-Whitney)
Comparison: Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.p-value: 0.56Wilcoxon (Mann-Whitney)
Secondary
Incidence of Adverse Events as a Measure of Patient Safety.
The number of patients who experienced an adverse event during the course of study is presented.
Time frame: Up to 114 days
Population: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GW-1000-02 | Incidence of Adverse Events as a Measure of Patient Safety. | 34 participants |
| GW-2000-02 | Incidence of Adverse Events as a Measure of Patient Safety. | 37 participants |
| Placebo | Incidence of Adverse Events as a Measure of Patient Safety. | 20 participants |