Trial · NCT04647877
Phenytoin Cream for the Treatment of Neuropathic Pain
NCT04647877, Phase 2, Phase 3, Completed, David J. Kopsky
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phenytoin Cream for the Treatment of Neuropathic Pain. Trials, record NCT04647877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04647877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phenytoin Cream for the Treatment of Neuropathic Pain
- NCT number
- NCT04647877
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- David J. Kopsky
- Conditions
- Chronic Idiopathic Axonal Polyneuropathy
- Interventions
- phenytoin cream, Placebo cream
- First posted
- 2020-12-01
- Last updated
- 2023-06-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in mean pain intensity measured on the 11-point numerical rating scale (NRS) between baseline and week 2 for phenytoin 20% cream versus placebo cream. | Mean baseline vs. mean of second week of each intervention | 0 = no pain, 10 = worst imaginable pain. The bigger the mean change, the better the outcome |
| Secondary | Change in mean pain intensity from baseline 11-point numerical rating scale (NRS) to the mean NRS in the second week in double-blind response test in positive and negative participants and all participants combined | Mean baseline vs. mean of second week of each intervention | 0 = no pain, 10 = worst imaginable pain. The bigger the mean change, the better the outcome |
| Secondary | Change of EuroQol (EQ5-5D-5L) from baseline to the end of the second week of each treatment period | Baseline vs. end of second week of each intervention | EQ5-5D-5L consists of 5 quality of life questions assessed on a 5 point scale: the lower the score, the better quality of life. Furthermore, a visual analogue scale from 0 to 100 is included. The higher the score, the better quality of life. |
| Secondary | Change of Neuropathic Pain Symptom Inventory (NPSI) from baseline to the end of the second week of each treatment period | Baseline vs. end of second week of each intervention | The NPSI consists of 10 neuropathic pain descriptors on the NRS, and 2 items assessing the duration of spontaneous ongoing and paroxysmal pain. The lower the score, the less pain. |
| Secondary | Change of subscales of the Brief Pain Inventory (sBPI) from baseline to the end of the second week of each treatment period | Baseline vs. end of second week of each intervention | The sBPI consists of 7 quality of life questions, assessed on the NRS. The lower the score, the better quality of life. |
| Secondary | Change of the 3 worst pain characteristics from baseline to the end of the second week of each treatment period | Baseline vs. end of second week of each intervention | The 3 worst pain characteristics are scored on the NRS. The lower the score, the less pain. |
| Secondary | Change of Patient Global Impression of Change Scale (PGIC) from baseline to the end of the second week of each treatment period | Baseline vs. end of second week of each intervention | The PGIC is a 7-point satisfaction scale. The lower the score, the better. |
| Secondary | 30 percent and 50 percent improvement or more on the NRS compared to placebo within one patient | Baseline vs. end of second week of each intervention | |
| Secondary | Time of carry-over effects after a treatment period | First week of each intervention | |
| Secondary | Onset of analgesic effect after application | At the end of second week of each intervention | The onset of analgesic effect will be noted in minutes. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT04647877
GET https://conductscience.org/api/trials/v1/NCT04647877/registered