Trial · NCT03749642
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of the average daily pain score based on the 11-point Numeric Rating Scale (NRS). | Baseline - Day 56 | The NRS is based on a 11-point from 0 for \[no pain\] to 10 \[worst possible pain\]. |
| Secondary | Change of the average daily pain score based on the 11-point Numeric Rating Scale (NRS). | Baseline - Days 7, 14, 21, 28, 42 | The NRS is based on a 11-point from 0 for \[no pain\] to 10 \[worst possible pain\]. |
| Secondary | Percentage of responder patients | Baseline - Day 56 | Responder patients are defined as ≥30% and ≥50% reduction from baseline of the average daily pain score based on the 11-point NRS. |
| Secondary | Change of the average daily pain score based on the 11-point NRS between gabapentin and placebo as assay sensitivity. | Baseline - Day 56 | The NRS is based on a 11-point from 0 for \[no pain\] to 10 \[worst possible pain\]. |
| Secondary | Change of Brief Pain Inventory Short Form (BPI-SF) items 3, 4, 5, 6, 8 and 9 score. | Baseline - Days 28, 56 | The BPI-SF is a numeric rating scale that assesses the severity of pain, its impact on daily functioning and other aspects of pain (e.g. location of pain, relief from medications). Items use a 0-10 numeric rating scale anchored at zero for "no pain" and 10 for "pain as bad as you can imagine" for Severity, and "does not interfere" to "completely interferes" for Interference. |
| Secondary | Change of Neuropathic Pain Symptom Inventory (NPSI) total score. | Baseline - Days 28, 56 | The NPSI is a self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain: It includes 10 descriptors plus two temporal items that allow discrimination and quantification of five distinct clinically relevant dimensions of neuropathic pain syndromes. |
| Secondary | Change of Beck Depression Inventory - Second Edition (BDI-II) | Baseline - Days 28, 56 | The BDI-II consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression and scored from 0 to 3. |
| Secondary | Change of Hospital Anxiety and Depression Scale (HADS). | Baseline - Days 28, 56 | The HADS is used to assess the level of anxiety and depression that a patient is experiencing. This is 14-item scale: seven related to the anxiety and seven to depression. Each item is scored from 0 to 3. |
| Secondary | Change of Insomnia Severity Index (ISI). | Baseline - Days 28, 56 | The ISI is a 7-item self-reported instrument measuring the patient's perception of his/her insomnia.Total score ranges from 0-28 and the following categorization is applicable: 0-7 = absence of insomnia; 8-14 = subthreshold insomnia; 15-21 = moderate insomnia; 22-28 = severe insomnia. |
| Secondary | Change of Euroqol-5D-5L (EQ-5D-5L) | Baseline - Days 28, 56 | The EQ-5D-5L consists of the EQ-5D descriptive system (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression assessed as no problems, slight problems, moderate problems, severe problems and extreme problems) and the EQ visual analogue scale (where the patient self-rates his/her health on a vertical visual analogue scale from 'The best health you can imagine' to 'The worst health you can imagine'). |
| Secondary | Clinical Global Improvement or Change (CGI-C). | Baseline - Days 28, 56 | CGI-C provides a global rating of patient's Improvement and scores range from "0 - not assessed" through to "7 - very much worse". |
| Secondary | Frequency of adverse events | 65 days | Monitoring of the treatment related adverse events. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03749642/registered