Trial Outcomes & Findings for A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin (NCT NCT01606176)
NCT ID: NCT01606176
Last Updated: 2023-01-10
Results Overview
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
0 - 3 weeks
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
GW-1000-02
Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
|
Placebo
Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
GW-1000-02
Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
|
Placebo
Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Disease progression
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin
Baseline characteristics by cohort
| Measure |
GW-1000-02
n=36 Participants
Active treatment.
|
Placebo
n=34 Participants
Placebo control.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
51.72 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
57.61 years
STANDARD_DEVIATION 10.28 • n=7 Participants
|
54.58 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Outcome measures
| Measure |
GW-1000-02
n=36 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.
|
-1.3 units on a scale
Standard Deviation 1.67
|
-0.9 units on a scale
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
The percentage of days on treatment on which escape medication was used is presented.
Outcome measures
| Measure |
GW-1000-02
n=36 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Use of Analgesic Escape Medication.
|
20.57 percentage of days
Standard Deviation 33.08
|
50.12 percentage of days
Standard Deviation 44.10
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Outcome measures
| Measure |
GW-1000-02
n=36 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.
|
-0.57 units on a scale
Standard Deviation 0.85
|
-0.34 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Outcome measures
| Measure |
GW-1000-02
n=28 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=26 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.
|
-5.9 units on a scale
Standard Deviation 10.17
|
-3.2 units on a scale
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
The Brief Pain Inventory (Short Form) 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 reduction in score from baseline indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=34 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.
|
-3.6 units on a scale
Standard Deviation 5.12
|
-1.9 units on a scale
Standard Deviation 6.52
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=33 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=31 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.
|
-0.2 units on a scale
Standard Deviation 1.17
|
-0.4 units on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented.
Outcome measures
| Measure |
GW-1000-02
n=36 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Patient Global Impression of Change at the End of 3 Weeks of Treatment.
|
9 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Outcome measures
| Measure |
GW-1000-02
n=24 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=19 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.
|
-1.6 units on a scale
Standard Deviation 1.90
|
-0.8 units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
The percentage of days on treatment on which escape medication was used is presented.
Outcome measures
| Measure |
GW-1000-02
n=24 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=19 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Use of Analgesic Escape Medication - Multiple Sclerosis Subset.
|
16.71 percentage of days
Standard Deviation 28.55
|
48.48 percentage of days
Standard Deviation 46.63
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Outcome measures
| Measure |
GW-1000-02
n=24 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=19 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.
|
-0.60 units on a scale
Standard Deviation 0.89
|
-0.36 units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Outcome measures
| Measure |
GW-1000-02
n=17 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=16 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.
|
-7.8 units on a scale
Standard Deviation 11.26
|
-1.7 units on a scale
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
The Brief Pain Inventory (Short Form) 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 reduction in score from baseline indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=23 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=19 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.
|
-4.5 units on a scale
Standard Deviation 5.60
|
-0.5 units on a scale
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=21 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=17 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.
|
-0.1 units on a scale
Standard Deviation 1.01
|
0.1 units on a scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: 0 - 3 weeksPopulation: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented.
Outcome measures
| Measure |
GW-1000-02
n=24 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=19 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Patient Global Impression of Change - Multiple Sclerosis Subset.
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 0 - 65 daysPopulation: All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.
The number of patients who experienced an adverse event in the study is presented.
Outcome measures
| Measure |
GW-1000-02
n=36 Participants
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 Participants
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Incidence of Adverse Events as a Measure of Patient Safety.
|
35 participants
|
26 participants
|
Adverse Events
GW-1000-02
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GW-1000-02
n=36 participants at risk
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 participants at risk
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Infections and infestations
Sepsis Not Otherwise Specified
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
1/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
Other adverse events
| Measure |
GW-1000-02
n=36 participants at risk
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
|
Placebo
n=34 participants at risk
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Urinary Tract Infection Not Otherwise Specified
|
11.1%
4/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
23.5%
8/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dizziness
|
55.6%
20/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
14.7%
5/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Headache Not Otherwise Specified
|
11.1%
4/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
14.7%
5/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Gait Abnormal Not Otherwise Specified
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Somnolence
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
13.9%
5/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Dry Mouth
|
11.1%
4/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Oral Discomfort
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Oral Pain
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Vomiting Not Otherwise Specified
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Diarrhoea Not Otherwise Specified
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.8%
3/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Application Site Pain
|
11.1%
4/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.8%
3/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Fatigue
|
11.1%
4/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling Drunk
|
8.3%
3/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Application Site Burning
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling of Relaxation
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Lethargy
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Thirst
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Weakness
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Confusional State
|
8.3%
3/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Euphoric Mood
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Paranoia
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.8%
3/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
Appetite Increased
|
8.3%
3/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Eye disorders
Vision Blurred
|
5.6%
2/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Pain in Limb
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Back Pain Aggravated
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Peripheral Swelling
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
Hypertension Not Otherwise Specified
|
0.00%
0/36 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
2/34 • All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
Additional Information
Mr Richard Potts, Clinical Operations Director
GW Pharma Ltd.
Phone: 0044 1223 266800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
- Publication restrictions are in place
Restriction type: OTHER