An Open-label, Extension Study, to Investigate the Long-term Safety and Tolerability of Cannabis Based Medicine Extracts in Patients With Cancer-related Pain.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- The Incidence of Adverse Events as a Measure of Subject Safety
Study Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
Detailed Description
Subjects who have previously participated in GWCA0101, 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® (containing delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD]) and GW-2000-02 (containing THC alone) in subjects with cancer-related pain are screened, and if eligible begin dosing with open-label Sativex®. They are allowed to self-titrate their study medication to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD and have the opportunity to request a change from Sativex® to GW-2000-02 if they or the investigator consider their response less than optimal. Subjects are reviewed for tolerability and evidence of clinical benefit at 7-10 days after Visit 1 and then every four weeks. Continuation within the study is conditional on satisfactory reports of tolerability, efficacy and dosing regime.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and eligible to continue into the extension study from GWCA
- •Complied adequately with the study requirements, as detailed in GWCA
- •In the investigator's opinion able to undertake and comply with all of the study requirements (it is understood that progress of the disease may accelerate and affect this ability).
- •Willing and able to read, consider and understand the subject information and consent form and to give written informed consent in compliance with the Declaration of Helsinki
- •Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation.
- •Willing for their name to be notified to the Home Office for participation in the trial.
Exclusion Criteria
- •Have not participated in GWCA
- •Have not complied adequately with the study requirements, as detailed in GWCA
- •Experienced an unacceptable adverse event, whilst participating in GWCA
- •Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
- •History of any type of schizophrenia, any other psychotic illness, a serious personality disorder, or other significant psychiatric illness other than depression associated with their chronic pain and/or in response to the underlying condition.
- •Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®).
- •Has a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
- •Has significant renal or hepatic impairment, which in the opinion of the investigator, are unsuitable for treatment with Investigational Medicinal Product.
- •History of epilepsy.
- •Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
- •If female, are pregnant or lactating, or are planning pregnancy during the course of the study and for three months thereafter.
- •Have oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth.
- •In the opinion of the investigator, are unsuitable to participate in the study for any other reason, not mentioned in the inclusion and exclusion criteria.
Arms & Interventions
Sativex
Active treatment
Intervention: Sativex (Drug)
GW-2000-02
Active treatment
Intervention: GW-2000-02 (Drug)
Outcomes
Primary Outcomes
The Incidence of Adverse Events as a Measure of Subject Safety
Time Frame: 0 - 657 days
The number of subjects who experienced an adverse event in this study is presented.
Secondary Outcomes
- Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment(0 - 657 days)
- Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment(0 - 657 days)