Trial · NCT00980746
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
NCT00980746, Phase 2, Completed, Bial - Portela C S.A.; results first posted 2013-05-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy. Trials, record NCT00980746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00980746
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
- NCT number
- NCT00980746
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 557 participants, actual
- Lead sponsor
- Bial - Portela C S.A.
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Eslicarbazepine acetate, Placebo
- First posted
- 2009-09-21
- Last updated
- 2016-06-22
- Other registries' IDs
- eudract:2007-002461-12
- Results first posted
- 2013-05-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | 17 weeks | Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | 17 weeks | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | ESL 1200 mg QD | -1.7546 | Standard Error 0.2352 | units on a scale | |
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | ESL 400 mg BD | -2.2865 | Standard Error 0.2325 | units on a scale | |
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | ESL 600 mg BID | -1.6746 | Standard Error 0.2312 | units on a scale | |
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | ESL 800 mg BID | -1.8353 | Standard Error 0.2260 | units on a scale | |
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | ESL 800 mg QD | -1.9829 | Standard Error 0.2328 | units on a scale | |
| Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain | Placebo | -1.5801 | Standard Error 0.2311 | units on a scale |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ESL 1200 mg QD | 85 | |
| Overall Study | STARTED | ESL 400 mg BD | 89 | |
| Overall Study | STARTED | ESL 600 mg BID | 95 | |
| Overall Study | STARTED | ESL 800 mg BID | 100 | |
| Overall Study | STARTED | ESL 800 mg QD | 92 | |
| Overall Study | STARTED | Placebo | 96 | |
| Overall Study | Randomized | ESL 1200 mg QD | 85 | |
| Overall Study | Randomized | ESL 400 mg BD | 89 | |
| Overall Study | Randomized | ESL 600 mg BID | 95 | |
| Overall Study | Randomized | ESL 800 mg BID | 100 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events108
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 | Nausea | General disorders | ESL 1200 mg QD | 0 | 85 | 0 |
| other | Nausea | General disorders | ESL 400 mg BD | 0 | 89 | 0 |
| other | Nausea | General disorders | ESL 600 mg BID | 7 | 95 | 7 |
| other | Nausea | General disorders | ESL 800 mg BID | 10 | 100 | 10 |
| other | Nausea | General disorders | ESL 800 mg QD | 0 | 92 | 0 |
| other | Nausea | General disorders | Placebo | 6 | 96 | 6 |
| other | Vomiting | Gastrointestinal disorders | ESL 1200 mg QD | 0 | 85 | 0 |
| other | Vomiting | Gastrointestinal disorders | ESL 400 mg BD | 0 | 89 | 0 |
| other | Vomiting | Gastrointestinal disorders | ESL 600 mg BID | 0 | 95 | 0 |
| other | Vomiting | Gastrointestinal disorders | ESL 800 mg BID | 10 | 100 | 10 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ESL 1200 mg QD | ||
| Total, all-cause mortality | ESL 400 mg BD | ||
| Total, all-cause mortality | ESL 600 mg BID | ||
| Total, all-cause mortality | ESL 800 mg BID | ||
| Total, all-cause mortality | ESL 800 mg QD | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ESL 1200 mg QD | 11 | 85 |
| Total, other adverse events | ESL 400 mg BD | 0 | 89 |
| Total, other adverse events | ESL 600 mg BID | 23 | 95 |
| Total, other adverse events | ESL 800 mg BID | 35 | 100 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT00980746
GET https://conductscience.org/api/trials/v1/NCT00980746/flow?page=2