Trial · NCT00870454
An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics
NCT00870454, Phase 2, Completed, SK Life Science, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics. Trials, record NCT00870454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00870454
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics
- NCT number
- NCT00870454
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 386 participants, actual
- Lead sponsor
- SK Life Science, Inc.
- Conditions
- Diabetic Neuropathies
- Interventions
- Pregabalin 300 mg/d, Carisbamate 800 mg/d, Carisbamate 1,200 mg/d, Placebo
- First posted
- 2009-03-27
- Last updated
- 2013-01-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean of the last 7 daily average diabetic peripheral neuropathy (DPN) pain scores | Through 15 weeks | |
| Secondary | Other secondary outcomes include the mean Neuropathic Pain Symptom Inventory (NPSI) subscale scores, the mean SF-36 subscale scores, and the Subject Global Impression of Change (SGIC) and Subject Global Impression of Severity (SGIS) scores. | Through 15 weeks | |
| Secondary | The proportion of patients who take rescue medication for breakthrough pain, and the number of days with rescue medication per week, will also be assessed. | Through 15 weeks | |
| Secondary | Responder rates (50% and 30% reduction from baseline in the mean of the last 7 daily average DPN pain scores). | Through 15 weeks | |
| Secondary | The mean of the last 7 daily maximum DPN pain scores. | Through 15 weeks | |
| Secondary | The mean of the last 7 Daily Sleep Interference scores. | Through 15 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT00870454
GET https://conductscience.org/api/trials/v1/NCT00870454/registered