PainPhase 3NCT00675948
Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain
A Phase 3 study testing Sativex and GW-2000-02 in people with Pain and Cancer, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Sativex and GW-2000-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2002to Sep 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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®).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Shropshire and Mid-Wales Hospice
Shrewsbury, SY3 8HS
About this study
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.
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
Read the 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.
- Being tested
- Sativex, GW-2000-02
- Keywords
- Palliative Care, Pain, Cancer
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called GW-1000-02
Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both 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:CBD 120 mg) in 24 hours.
GW-2000-02Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sativex | Experimental | Active treatment Receives: Drug: Sativex |
| GW-2000-02 | Experimental | Active treatment Receives: Drug: GW-2000-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Events as a Measure of Subject Safety
The number of subjects who experienced an adverse event in this study is presented.
Measured: 0 - 657 days
Secondary outcomes (2)
Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment
The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects 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 negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.
Measured: 0 - 657 days
Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment
The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.
Measured: 0 - 657 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy R Johnson, MB ChB, Principal investigator, Shropshire and Mid-Wales Hospice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675948
- Sponsor's protocol ID
- GWEXT0101
- Status last verified
- Apr 2023
- First submitted
- 8 May 2008
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23141881
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00675948
- Acronym / sponsor ID
- GWEXT0101
- Keywords
- Palliative Care, Pain, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 13 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sativex | Experimental | Drug: SativexActive treatment |
| GW-2000-02 | Experimental | Drug: GW-2000-02Active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SativexAlso: GW-1000-02Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both 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:CBD 120 mg) in 24 hours. | Drug | Sativex |
| GW-2000-02Containing 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. | Drug | GW-2000-02 |
Primary outcome
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.
2 secondary outcomes
Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment
Time frame: 0 - 657 days
Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment
Time frame: 0 - 657 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23141881Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy R Johnson, MB ChB principal investigator
Shropshire and Mid-Wales Hospice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sativex and GW-2000-02 in people with Pain and Cancer, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Adverse Events as a Measure of Subject Safety (time frame: 0 - 657 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.