Trial · NCT00713323
A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.
NCT00713323, 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 to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain. Trials, record NCT00713323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00713323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.
- NCT number
- NCT00713323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 380 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Pain, Peripheral Neuropathy
- Interventions
- Sativex®
- First posted
- 2008-07-11
- Last updated
- 2023-05-03
- Results first posted
- 2012-09-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment | 38 weeks | The average 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. A negative value indicates an improvement in pain score from baseline. |
| Secondary | Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38) | 38 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. |
| Secondary | Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38) | 38 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. |
| Secondary | Subject Global Impression of Change | week 38 | A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain 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 which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported. |
| Secondary | Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment | 38 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. |
| Secondary | Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment | 38 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. |
| Secondary | Incidence of Adverse Events as a Measure of Subject Safety | 42 weeks | The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment). |
| Secondary | Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks) | 38 weeks | The patient was asked "on a scale of '0 to 10' please indicate the average level of your intoxication due to medications over the last 24 hours" (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment | 38 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38) | 38 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38) | 38 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Subject Global Impression of Change | week 38 | All subjects who received at least one dose of open-label Sativex were included in the analysis. | participants | NUMBER |
| SECONDARY | Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment | 38 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment | 38 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Incidence of Adverse Events as a Measure of Subject Safety | 42 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | participants | NUMBER |
| SECONDARY | Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks) | 38 weeks | All subjects who received at least one dose of open-label Sativex were included in the analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment | Sativex | -2.07 | Standard Deviation 2.13 | units on a scale | |
| Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38) | Sativex | -15.67 | Standard Deviation 19.11 | units on a scale | |
| Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38) | Sativex | -1.76 | Standard Deviation 2.93 | units on a scale | |
| Subject Global Impression of Change | Sativex | Very Much Improved | 41 | participants | |
| Subject Global Impression of Change | Sativex | Much Improved | 107 | participants | |
| Subject Global Impression of Change | Sativex | Slightly Improved | 99 | participants | |
| Subject Global Impression of Change | Sativex | No change | 79 | participants | |
| Subject Global Impression of Change | Sativex | Slightly worse | 14 | participants | |
| Subject Global Impression of Change | Sativex | Much worse | 12 | participants | |
| Subject Global Impression of Change | Sativex | Very much worse | 4 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sativex | 380 | |
| Overall Study | COMPLETED | Sativex | 234 | |
| Overall Study | NOT COMPLETED | Sativex | 146 |
Source ClinicalTrials.gov
Adverse events87
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 | 79 | 380 | |
| other | Dysgeusia | Nervous system disorders | Sativex | 29 | 380 | |
| other | Somnolence | Nervous system disorders | Sativex | 28 | 380 | |
| other | Headache | Nervous system disorders | Sativex | 23 | 380 | |
| other | Balance Disorder | Nervous system disorders | Sativex | 12 | 380 | |
| other | Memory Impairment | Nervous system disorders | Sativex | 12 | 380 | |
| other | Nausea | Gastrointestinal disorders | Sativex | 42 | 380 | |
| other | Dry Mouth | Gastrointestinal disorders | Sativex | 30 | 380 | |
| other | Vomiting | Gastrointestinal disorders | Sativex | 25 | 380 | |
| other | Diarrhoea | Gastrointestinal disorders | Sativex | 17 | 380 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sativex | ||
| Total, other adverse events | Sativex | 295 | 380 |
| Total, serious adverse events | Sativex | 40 | 380 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT00713323
GET https://conductscience.org/api/trials/v1/NCT00713323/events?page=2