Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Cancer Pain

Pain

Marijuana Abuse

Anticonvulsants

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

Cannabidiol

Dronabinol

Nabiximols

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.

Placebo

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.

Sativex®

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.

THC Alone

Jeremy R Johnson, MB ChB

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.

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).

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy

A Double Blind, Randomized, Parallel Group, Placebo Controlled, Comparative Study of the Efficacy, Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-related Pain.

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.

Subjects recorded their use of escape medication each day on their diary card.

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.

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.

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.

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.

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.

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

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.

Jazz Pharmaceuticals

Mr Richard Potts/ Clinical Operations Director

All AEs occurring during the study were reported on the running logs at the back of the study case report form.

Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD

Sativex

Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC

Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD

Each 100 uL actuation contained 27 mg/ml THC

Each 100 uL actuation contained colourant and excipients

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Belgium

Romania

Region of Enrollment

Mr Richard Potts, Clinical Operations Director

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.

Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.

Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

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.

The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.

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.

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.

Sleep Disturbance 0-10 Numerical Rating Scale

Nausea 0-10 Numerical Rating Scale

Memory 0-10 Numerical Rating Scale

Appetite 0-10 Numerical Rating Scale

Concentration 0-10 Numerical Rating Scale

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.

EORTC Quality of Life Questionnaire (EORTC-QLQC30)

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.

Brief Pain Inventory Short Form

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.

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.

Spots Global Cancer Trial Database for thc alone

Every month we try and update this database with for thc alone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for thc alone

Every month we try and update this database with for thc alone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for thc alone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.