Trial · NCT04647877
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Duration of analgesic effect | At the end of second week of each intervention | The duration of analgesic effect will be noted in hours. |
| Secondary | Daily number of cream applications | At the end of second week of each intervention | |
| Secondary | Percentage of analgesic effect as rated by the participant | At the end of second week of each intervention. | The participant will be asked about the percentage of pain reduction at the end of the second week of each intervention. The higher, the better. |
| Secondary | Local and/or systemic side effects | During the 6 weeks of double-blind phase and 1 year open phase | At each visit and telephone call participants will be asked about possibly occurring side effects. |
| Secondary | Detection of phenytoin in plasma | At the end of second week of first treatment period | Two hours after last application phenytoin plasma level will be evaluated |
| Secondary | Predictive value of DOBRET | Baseline vs. mean of second week of each intervention | Correlation with DOBRET response and mean pain reduction while using phenytoin 10 percent or 20 percent cream. The stronger the correlation, the more predictive the DOBRET is. |
| Secondary | Use of escape pain medication | During the 6 weeks of double-blind phase and 1 year open phase | The daily amount of acetaminophen and/or non-steroid anti-inflammatory drugs |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04647877/registered