Trial · NCT00710554
A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With Allodynia
NCT00710554, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2012-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With Allodynia. Trials, record NCT00710554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00710554
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With Allodynia
- NCT number
- NCT00710554
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 246 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Pain, Peripheral Neuropathy
- Interventions
- Sativex, Placebo
- First posted
- 2008-07-04
- Last updated
- 2023-05-03
- Results first posted
- 2012-09-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | Day 7 to Day 98 | 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. |
| Secondary | Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | Day 7 to Day 98 | 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. |
| Secondary | Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) | Day 7 to Day 98 | 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. |
| Secondary | Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | Day 7 and Day 98 | 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. |
| Secondary | Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | Day 7 and Day 98 | 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). |
| Secondary | Subject Global Impression of Change | Day 98 | 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. |
| Secondary | Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment | Day 7 and Day 98 | 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. |
| Secondary | Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks) | Day 7 and Day 98 | 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. |
| Secondary | Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks) | Day 7 and Day 98 | 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. |
| Secondary | Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks) | Days 0-7 and Days 92-98 | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | Day 7 to Day 98 | The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | Day 7 to Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) | Day 7 to Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | Day 7 and Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | Day 7 and Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Subject Global Impression of Change | Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | participants | NUMBER |
| SECONDARY | Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment | Day 7 and Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks) | Day 7 and Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks) | Day 7 and Day 98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks) | Days 0-7 and Days 92-98 | The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data. | number of tablets | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | Sativex | -1.36 | Standard Deviation 2.02 | units on a scale | |
| Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks) | Placebo | -0.84 | Standard Deviation 1.86 | units on a scale | |
| Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | Sativex | -11.57 | Standard Deviation 16.15 | units on a scale | |
| Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks) | Placebo | -7.19 | Standard Deviation 19.65 | units on a scale | |
| Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) | Sativex | -2.0 | Standard Deviation 2.70 | units on a scale | |
| Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks) | Placebo | -1.2 | Standard Deviation 2.38 | units on a scale | |
| Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | Sativex | -1.1 | Standard Deviation 2.16 | units on a scale | |
| Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks) | Placebo | -1.0 | Standard Deviation 2.49 | units on a scale | |
| Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | Sativex | 0.2 | Standard Deviation 0.78 | units on a scale | |
| Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks) | Placebo | 0.3 | Standard Deviation 1.08 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sativex | 128 | |
| Overall Study | STARTED | Placebo | 118 | |
| Overall Study | COMPLETED | Sativex | 79 | |
| Overall Study | COMPLETED | Placebo | 94 | |
| Overall Study | NOT COMPLETED | Sativex | 49 | |
| Overall Study | NOT COMPLETED | Placebo | 24 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Sativex | 52 | 128 | |
| other | Dizziness | Nervous system disorders | Placebo | 12 | 118 | |
| other | Dysgeusia | Nervous system disorders | Sativex | 14 | 128 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 2 | 118 | |
| other | Headache | Nervous system disorders | Sativex | 13 | 128 | |
| other | Headache | Nervous system disorders | Placebo | 9 | 118 | |
| other | Disturbance in Attention | Nervous system disorders | Sativex | 8 | 128 | |
| other | Disturbance in Attention | Nervous system disorders | Placebo | 2 | 118 | |
| other | Neuropathy Peripheral | Nervous system disorders | Sativex | 6 | 128 | |
| other | Neuropathy Peripheral | Nervous system disorders | Placebo | 4 | 118 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sativex | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sativex | 109 | 128 |
| Total, other adverse events | Placebo | 83 | 118 |
| Total, serious adverse events | Sativex | 10 | 128 |
| Total, serious adverse events | Placebo | 6 | 118 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24420962 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sativex vs Placebo: Incidence of Adverse Events as a Measure of Subject's Safety. | Trial comparisons |
| Sativex vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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