Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. MedDRA version: 15.0 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
GW Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients must fulfill ALL of the following criteria: -Patient is aged 18 years or above. -The patient has advanced cancer. -The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current optimized opioid treatment. -The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a ?regular maintenance dose of around the clock use of immediate release preparations. -The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and/or break-through opioids). -The patient is using no more than one type of break-through opioid analgesia. - The patient is willing to continue to take their maintenance opioid therapy at the same daily dose, throughout the duration of the study where possible. - Has satisfactorily completed the IVRS and willing to continue to do so. - Willing and able to give written informed consent. - Willing and able to comply with all study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 190
Exclusion criteria
Exclusion criteria: Exclusion: The patient may not enter the study if ANY of the following apply: - Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain). - The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study. - Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. - Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug. - Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year). - Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP. - Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically significant arrhythmia or myocardial infarction. - Has significantly impaired renal function as evidenced by a creatinine clearance lower than 40 mL/min at Visit 1. - Has significantly impaired hepatic function at Visit 1 - Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective). - Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. - Patients who have received a non-approved investigational product within 30 days of Visit 1. - Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study. - Travel outside the country of residence planned during the study. - Patients previously randomized into this study or any other Sativex clinical trial for Cancer Pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Sativex, when used as an adjunctive (not breakthrough) measure, compared with placebo in relieving uncontrolled persistent chronic pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.;Secondary Objective: To evaluate the efficacy of Sativex compared with placebo on: • Secondary measures of pain. • Sleep disruption. • Constipation • Opioid consumption • Change in general function To evaluate the safety and tolerability of Sativex compared with placebo through the following assessments: • Adverse Events (AE) • Survival • Suicidal Tendencies (Columbia Suicide Severity Rating Scale - C-SSRS) • Clinical laboratory tests • Vital signs;Primary end point(s): The primary endpoint is the percent improvement from baseline to the end of treatment in NRS average pain score. The plot of the percent improvement versus proportion of responders is also referred to as the continuous response analysis.;Timepoint(s) of evaluation of this end point: Last 7 days of IMP treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following key secondary endpoints will have their Type I error controlled by a hierarchical testing procedure: • Change from baseline in mean NRS average pain. • Change from baseline in mean NRS worst pain. • Change from baseline in mean Sleep Disruption NRS The remaining secondary efficacy endpoints are: • Subject Global Impression of Change (SGIC) • Change from baseline in mean total opioid (morphine equivalence) use • Change from baseline in mean daily maintenance dose opioid (morphine quivalence) use • Change from baseline in mean break-through opioid usage (morphine equivalence) use • Change from baseline in constipation NRS • Physician Global Impression of Change in general function (PGIC) • Patient Satisfaction Questionnaire (PSQ);Timepoint(s) of evaluation of this end point: The 'diary data based' end of treatment values will be calculated using the same rules as for the primary endpoint – i.e., last 7 days of IMP treatment. The other end of treatment values will use the 'End of Treatment' Visit assessment data. | — |
Countries
Belgium, Bulgaria, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, United Kingdom, United States
Contacts
Public ContactGW Pharma Ltd. Switchboard.
GW Pharma Ltd.
Outcome results
None listed