Clinical trial NCT00675948: Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain
Official title: An Open-label, Extension Study, to Investigate the Long-term Safety and Tolerability of Cannabis Based Medicine Extracts in Patients With Cancer-related Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Cancer
Keywords: Palliative Care
Pain
Cancer
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Willing and eligible to continue into the extension study from GWCA0101.
* Complied adequately with the study requirements, as detailed in GWCA0101.
* 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 Helsinki1.
* 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 GWCA0101.
* Have not complied adequately with the study requirements, as detailed in GWCA0101.
* Experienced an unacceptable adverse event, whilst participating in GWCA0101.
* 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.

Primary outcomes:
measure: The Incidence of Adverse Events as a Measure of Subject Safety
timeFrame: 0 - 657 days
Secondary outcomes:
measure: Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment
timeFrame: 0 - 657 days
measure: Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment
timeFrame: 0 - 657 days
Other outcomes:
Locations:
city: Shrewsbury
country: United Kingdom
facility: Shropshire and Mid-Wales Hospice
Study officials:
affiliation: Shropshire and Mid-Wales Hospice
name: Jeremy R Johnson, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson JR, Lossignol D, Burnell-Nugent M, Fallon MT. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage. 2013 Aug;46(2):207-18. doi: 10.1016/j.jpainsymman.2012.07.014. Epub 2012 Nov 8.