A Phase 3 interventional study of Sativex and Placebo in Pain and Peripheral Neuropathy, 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 evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 246 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Jazz Pharmaceuticals is the lead sponsor of 173 studies on the registry; 18 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 32 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Sativex
Drug: Placebo
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Also known as: GW-1000-02
containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
Also known as: GW-4001-01
Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)
The peripheral neuropathic pain 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 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. A negative value indicates an improvement in pain score from baseline.
Time frame: Day 7 to Day 98
Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)
The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Time frame: Day 7 to Day 98
Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)
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.
Time frame: Day 7 to Day 98
Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)
Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.
Time frame: Day 7 and Day 98
Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)
Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).
Time frame: Day 7 and Day 98
Subject Global Impression of Change
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Time frame: Day 98
Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment
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.
Time frame: Day 7 and Day 98
Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
Time frame: Day 7 and Day 98
Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
Time frame: Day 7 and Day 98
Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)
Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.
Time frame: Days 0-7 and Days 92-98
Incidence of Adverse Events as a Measure of Subject's Safety.
The number of subjects that reported an adverse event in this study is presented.
Time frame: 19 weeks
| Milestone | Sativex | Placebo |
|---|---|---|
| Started | 128 | 118 |
| Completed | 79 | 94 |
| Not completed | 49 | 24 |
| Withdrew: Adverse event | 24 | 7 |
| Withdrew: Withdrawal by subject | 7 | 3 |
| Withdrew: Lost to follow-up | 7 | 1 |
| Withdrew: Lack of efficacy | 11 | 12 |
| Withdrew: Receiving radiotherapy - prostate cancer | 0 | 1 |
The peripheral neuropathic pain 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 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. A negative value indicates an improvement in pain score from baseline.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | -1.36 ± 2.02 | -0.84 ± 1.86 |
The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | -11.57 ± 16.15 | -7.19 ± 19.65 |
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.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) | -2.0 ± 2.70 | -1.2 ± 2.38 |
Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | -1.1 ± 2.16 | -1.0 ± 2.49 |
Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | 0.2 ± 0.78 | 0.3 ± 1.08 |
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
| participants | Sativex | Placebo |
|---|---|---|
| Very much improved | 8 | 4 |
| Much improved | 16 | 10 |
| Slightly improved | 38 | 24 |
| No change | 44 | 66 |
| Slightly worse | 9 | 4 |
| Much worse | 2 | 3 |
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.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment | -0.9 ± 1.69 | -0.6 ± 1.90 |
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks) | 0.037 ± 0.187 | 0.044 ± 0.214 |
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
| units on a scale | Sativex | Placebo |
|---|---|---|
| Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks) | 3.7 ± 20.6 | 2.5 ± 21.2 |
Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.
| number of tablets | Sativex | Placebo |
|---|---|---|
| Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks) | -0.99 ± 2.20 | -0.47 ± 2.08 |
The number of subjects that reported an adverse event in this study is presented.
| participants | Sativex | Placebo |
|---|---|---|
| Incidence of Adverse Events as a Measure of Subject's Safety. | 109 | 83 |
Collected over All adverse events occurring from the time of consent to post study follow up i.e. 19 weeks were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sativex | — | 10/128 (7.8%) | 109/128 (85.2%) |
| Placebo | — | 6/118 (5.1%) | 83/118 (70.3%) |
| Event | Sativex | Placebo |
|---|---|---|
| ComaNervous system disorders | 0/128 | 1/118 |
| DizzinessNervous system disorders | 0/128 | 1/118 |
| Loss of ConsciousnessNervous system disorders | 0/128 | 1/118 |
| Enterovesical FistulaGastrointestinal disorders | 0/128 | 1/118 |
| Head InjuryInjury, poisoning and procedural complications | 0/128 | 1/118 |
| Joint DislocationInjury, poisoning and procedural complications | 0/128 | 1/118 |
| Lumbar Vertebral fractureInjury, poisoning and procedural complications | 0/128 | 1/118 |
| Road Traffic AccidentInjury, poisoning and procedural complications | 0/128 | 1/118 |
| Soft Tissue InjuryInjury, poisoning and procedural complications | 0/128 | 1/118 |
| Deep Vein ThrombosisVascular disorders | 0/128 | 1/118 |
| Event | Sativex | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 52/128 | 12/118 |
| NauseaGastrointestinal disorders | 23/128 | 14/118 |
| FatigueGeneral disorders | 20/128 | 8/118 |
| DysgeusiaNervous system disorders | 14/128 | 2/118 |
| HeadacheNervous system disorders | 13/128 | 9/118 |
| VomitingGastrointestinal disorders | 13/128 | 7/118 |
| DiarrhoeaGastrointestinal disorders | 12/128 | 6/118 |
| Dry MouthGastrointestinal disorders | 11/128 | 4/118 |
| DissociationPsychiatric disorders | 9/128 | 0/118 |
| NasopharyngitisInfections and infestations | 9/128 | 8/118 |
| Age, Categorical(Participants) | Sativex | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 91 | 88 | 179 |
| >=65 years | 37 | 30 | 67 |
| Age, Continuous(years) | Sativex | Placebo | Total |
|---|---|---|---|
| Mean | 57.6 ± 14.38 | 57 ± 14.07 | 57.3 ± 14.21 |
| Sex: Female, Male(Participants) | Sativex | Placebo | Total |
|---|---|---|---|
| Female | 85 | 65 | 150 |
| Male | 43 | 53 | 96 |
| Region of Enrollment(participants) | Sativex | Placebo | Total |
|---|---|---|---|
| United Kingdom | 74 | 72 | 146 |
| Belgium | 8 | 7 | 15 |
| Canada | 3 | 2 | 5 |
| Czech Republic | 35 | 32 | 67 |
| Romania | 8 | 5 | 13 |
The record gives a start of Aug 2005, a primary completion of Oct 2006 and a completion of Oct 2006. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2012, 5 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Nabiximols