A Phase 3 interventional study of Sativex and GW-2000-02 in Pain and Cancer, sponsored by Jazz Pharmaceuticals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Jazz Pharmaceuticals · Phase 3, Interventional, and Supportive care
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
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.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 43 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
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Exclusion Criteria:
Active treatment
Drug: Sativex
Active treatment
Drug: GW-2000-02
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.
Also known as: GW-1000-02
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.
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.
Time frame: 0 - 657 days
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.
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
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.
Time frame: 0 - 657 days
The first subject was recruited on the 30th April 2002
| Milestone | Sativex | THC Alone |
|---|---|---|
| Started | 39 | 4 |
| Completed | 0 | 1 |
| Not completed | 39 | 3 |
| Withdrew: Adverse event | 23 | 1 |
| Withdrew: Lack of efficacy | 3 | 0 |
| Withdrew: Withdrawal by subject | 7 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Pain under control | 1 | 0 |
| Withdrew: Sponsor decision | 0 | 1 |
| Withdrew: Patient died | 1 | 0 |
| Withdrew: Patient unable to comply with diaries | 1 | 0 |
| Withdrew: Patient feels unable to take medication | 0 | 1 |
The number of subjects who experienced an adverse event in this study is presented.
| participants | Sativex | THC Alone |
|---|---|---|
| The Incidence of Adverse Events as a Measure of Subject Safety | 37 | 4 |
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.
| units on a scale | Sativex | THC Alone |
|---|---|---|
| Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment | -0.53 ± 1.28 | — |
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.
| units on a scale | Sativex | THC Alone |
|---|---|---|
| Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment | -2.0 ± 28.34 | — |
Collected over All adverse events (AEs) occurring from the time of consent to post study follow up (2 - 521 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sativex | — | 20/39 (51.3%) | 37/39 (94.9%) |
| THC Alone | — | 1/4 (25%) | 4/4 (100%) |
| Event | Sativex | THC Alone |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 8/39 | 1/4 |
| HaematemesisGastrointestinal disorders | 2/39 | 0/4 |
| ConfusionPsychiatric disorders | 2/39 | 0/4 |
| Anaemia NOS aggravatedBlood and lymphatic system disorders | 1/39 | 0/4 |
| Atrial fibrillationCardiac disorders | 1/39 | 0/4 |
| Diarrhoea NOSGastrointestinal disorders | 1/39 | 0/4 |
| Intestinal obstruction NOSGastrointestinal disorders | 1/39 | 0/4 |
| NauseaGastrointestinal disorders | 1/39 | 0/4 |
| Vomiting NOSGastrointestinal disorders | 1/39 | 0/4 |
| General physical health deteriorationGeneral disorders | 1/39 | 0/4 |
| Event | Sativex | THC Alone |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 11/39 | 1/4 |
| NauseaGastrointestinal disorders | 10/39 | 0/4 |
| VomitingGastrointestinal disorders | 10/39 | 1/4 |
| DizzinessNervous system disorders | 8/39 | 1/4 |
| HeadacheNervous system disorders | 2/39 | 1/4 |
| Memory impairmentNervous system disorders | 0/39 | 1/4 |
| ConfusionPsychiatric disorders | 7/39 | 1/4 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/39 | 1/4 |
| CholelithiasisHepatobiliary disorders | 0/39 | 1/4 |
| CellulitisInfections and infestations | 0/39 | 1/4 |
| Age, Categorical(Participants) | Sativex | THC Alone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 4 | 33 |
| >=65 years | 10 | 0 | 10 |
| Age, Continuous(years) | Sativex | THC Alone | Total |
|---|---|---|---|
| Mean | 57.5 ± 13.5 | 58.6 ± 6.28 | 57.6 ± 12.94 |
| Sex: Female, Male(Participants) | Sativex | THC Alone | Total |
|---|---|---|---|
| Female | 16 | 3 | 19 |
| Male | 23 | 1 | 24 |
| Region of Enrollment(participants) | Sativex | THC Alone | Total |
|---|---|---|---|
| United Kingdom | 31 | 3 | 34 |
| Belgium | 8 | 1 | 9 |
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Jazz Pharmaceuticals