Palliative CarePhase 3SPRAYNCT00674609
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy
A Phase 3 study testing Sativex® and THC Alone in people with Palliative Care and Pain, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Pain, Cancer
- What is being tested?
- Sativex® and THC Alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2002to Mar 2004
- 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 able to give informed consent.
- Male or female, age 18 years or above.
- Diagnosed with cancer of any type, which is considered to be terminal.
- Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose level of pain measured on a NRS is ³four on at least one occasion per day, during the two day run-in period, leading up to visit 1.
- On strong opioid maintenance therapy for at least seven days prior to the screening visit.
- Willing to abstain from any use of cannabis during the study, other than the study medication.
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- No cannabinoids use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabis during the study.
- Clinically acceptable blood results at the screening visit.
- Able (in the investigators opinion) and willing to undertake and comply with all study requirements.
- Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation.
- Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).
Who cannot join
- Know history of substance misuse.
- Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
- Received any epidural analgesia within 48 hours prior to study entry.
- Either received, within two weeks of study entry, or due to receive chemotherapy or radiotherapy during the study.
- Unable to give informed consent.
- 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.
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- Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®).
- Had a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
- Significant renal or hepatic impairment, who in the opinion of the investigator, were unsuitable for treatment with study medication.
- History of epilepsy.
- Had oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth.
- Female subjects who were pregnant or lactating or of child-bearing potential and were inadequately protected against conception during the study and for three months thereafter.
- Male subjects who were sexually active and who were not using adequate forms of contraception during the study and for three months thereafter.
- Subjects who had participated in a clinical research study in the past four weeks, prior to study entry.
- Planned travel outside the UK during the study (applicable to the UK centres only).
- Subjects who, in the opinion of the investigator, were unsuitable to participate in the study for any other reason, not mentioned in the entry 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: 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 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.
Read the detailed description
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).
- Conditions
- Palliative Care, Pain, Cancer
- Being tested
- Placebo, Sativex®, THC Alone
- 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.
PlaceboDrug
Also called GW-4000-01
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.
Sativex®Drug
Also called GW-1000-02
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.
THC AloneDrug
Also called GW-2000-02, THC
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 |
|---|---|---|
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
| Sativex | Experimental | Active treatment Receives: Drug: Sativex® |
| THC Alone | Experimental | Active treatment Receives: Drug: THC Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
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.
Measured: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
The Consumption of Escape Analgesic Medication.
Subjects recorded their use of escape medication each day on their diary card.
Measured: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Secondary outcomes (7)
Sleep Disturbance 0-10 Numerical Rating Scale
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.
Measured: 2 weeks: baseline to end of week 2 (last 3 days of treatment)
Nausea 0-10 Numerical Rating Scale
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.
Measured: 2 weeks; baseline - end of week 2 (last 3 days of treatment)
Memory 0-10 Numerical Rating Scale
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.
Measured: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Appetite 0-10 Numerical Rating Scale
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.
Measured: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Concentration 0-10 Numerical Rating Scale
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.
Measured: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
EORTC Quality of Life Questionnaire (EORTC-QLQC30)
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
Measured: 2 weeks; baseline and end of treatment (2 weeks)
Brief Pain Inventory Short Form
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.
Measured: End of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startFeb 2002
- Primary completionFeb 2004
- Study completionMar 2004
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 Palliative CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeremy R Johnson, MB ChB, Principal investigator, Shropshire and Mid-Wales Hospice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674609
- Sponsor's protocol ID
- GWCA0101
- Acronym
- SPRAY
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2008
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.
PubMed 19896326
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
- 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.
- ClinicalTrials.gov ID
- NCT00674609
- Acronym / sponsor ID
- SPRAY / GWCA0101
- Conditions
- Palliative Care, Pain, Cancer
- Keywords
- Palliative Care, Pain, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 13 Aug 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 determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control |
| Sativex | Experimental | Drug: Sativex®Active treatment |
| THC Alone | Experimental | Drug: THC AloneActive treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing and able to give informed consent.
- Male or female, age 18 years or above.
- Diagnosed with cancer of any type, which is considered to be terminal.
- Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose level of pain measured on a NRS is ³four on at least one occasion per day, during the two day run-in period, leading up to visit 1.
- On strong opioid maintenance therapy for at least seven days prior to the screening visit.
Key exclusion criteria (16 listed)
- Know history of substance misuse.
- Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
- Received any epidural analgesia within 48 hours prior to study entry.
- Either received, within two weeks of study entry, or due to receive chemotherapy or radiotherapy during the study.
- Unable to give informed consent.
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 |
|---|---|---|
| PlaceboAlso: GW-4000-01Containing 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. | Drug | Placebo |
| Sativex®Also: GW-1000-02Containing 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. | Drug | Sativex |
| THC AloneAlso: GW-2000-02, THCContaining 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 | THC Alone |
Primary outcome
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
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.
The Consumption of Escape Analgesic Medication.
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Subjects recorded their use of escape medication each day on their diary card.
7 secondary outcomes
Sleep Disturbance 0-10 Numerical Rating Scale
Time frame: 2 weeks: baseline to end of week 2 (last 3 days of treatment)
Nausea 0-10 Numerical Rating Scale
Time frame: 2 weeks; baseline - end of week 2 (last 3 days of treatment)
Memory 0-10 Numerical Rating Scale
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Appetite 0-10 Numerical Rating Scale
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Concentration 0-10 Numerical Rating Scale
Time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
EORTC Quality of Life Questionnaire (EORTC-QLQC30)
Time frame: 2 weeks; baseline and end of treatment (2 weeks)
Brief Pain Inventory Short Form
Time frame: End of 2 weeks
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 19896326Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.
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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 THC Alone in people with Palliative Care and Pain, 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 11 inclusion and 16 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. Some participants in this study may receive a placebo. 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 Aug 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 Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. (time frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment)). The study lists 2 primary outcomes in all. 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 NCT00674609, 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.