Trial · NCT03749642
Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy
NCT03749642, Phase 2, Completed, Aziende Chimiche Riunite Angelini Francesco S.p.A
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy. Trials, record NCT03749642. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03749642
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy
- NCT number
- NCT03749642
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 240 participants, actual
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- trazodone/gabapentin 2.5/25 mg, trazodone/gabapentin 5/50 mg, trazodone/gabapentin 10/100, Gabapentin, Placebo oral capsule
- First posted
- 2018-11-21
- Last updated
- 2021-05-27
- Other registries' IDs
- eudract:2018-000133-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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'). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38914876 | DERIVED |
Source PubMed
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/NCT03749642
GET https://conductscience.org/api/trials/v1/NCT03749642/registered