Trial · NCT03219320
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT03219320, Phase 2, Completed, Aptinyx; results first posted 2020-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy. Trials, record NCT03219320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03219320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- NCT number
- NCT03219320
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 301 participants, actual
- Lead sponsor
- Aptinyx
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- NYX-2925, Placebo
- First posted
- 2017-07-17
- Last updated
- 2020-06-09
- Results first posted
- 2020-06-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numeric Rating Scale (NRS) Average Pain Intensity | From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28) | Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable |
| Secondary | Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline | baseline to week 4 | Change in the NRS score assessing average pain intensity in the past 24 hours for patients who did not use a concomitant medication at baseline; 0=no pain, 10=worst pain imaginable |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numeric Rating Scale (NRS) Average Pain Intensity | From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28) | All subjects who were included in the safety population, were randomized, and had at least 4 post-baseline daily average pain scores are included in the efficacy population. \[mixed effects repeated measures (MMRM)\] | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline | baseline to week 4 | All subjects who were included in the safety population, were randomized, and had at least 4 post-baseline daily average pain scores are included in the efficacy population. \[mixed effects repeated measures (MMRM)\] | score on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Numeric Rating Scale (NRS) Average Pain Intensity in Subjects With DPN >= 4 Years | baseline to week 4 | All subjects who were included in the safety population, were randomized, and had at least 4 post-baseline daily average pain scores are included in the efficacy population. \[mixed effects repeated measures (MMRM)\] | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numeric Rating Scale (NRS) Average Pain Intensity | NYX-2925 200 mg QD | -1.50 | Standard Error 0.19 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity | NYX-2025 50 mg QD | -1.61 | Standard Error 0.19 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity | NYX-2925 10 mg QD | -1.15 | Standard Error 0.19 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity | Placebo QD | -1.23 | Standard Error 0.19 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline | NYX-2925 200 mg QD | -1.55 | Standard Error 0.28 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline | NYX-2025 50 mg QD | -1.62 | Standard Error 0.26 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline | NYX-2925 10 mg QD | -1.42 | Standard Error 0.29 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline | Placebo QD | -1.03 | Standard Error 0.29 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity in Subjects With DPN >= 4 Years | NYX-2925 200 mg QD | -1.19 | Standard Error 0.27 | score on a scale | |
| Numeric Rating Scale (NRS) Average Pain Intensity in Subjects With DPN >= 4 Years | NYX-2025 50 mg QD | -1.93 | Standard Error 0.31 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NYX-2925 200 mg Once Daily (QD) | 75 | |
| Overall Study | STARTED | NYX-2925 50 mg QD | 77 | |
| Overall Study | STARTED | NYX-2925 10 mg QD | 77 | |
| Overall Study | STARTED | Placebo QD | 72 | |
| Overall Study | COMPLETED | NYX-2925 200 mg Once Daily (QD) | 73 | |
| Overall Study | COMPLETED | NYX-2925 50 mg QD | 74 | |
| Overall Study | COMPLETED | NYX-2925 10 mg QD | 72 | |
| Overall Study | COMPLETED | Placebo QD | 69 | |
| Overall Study | NOT COMPLETED | NYX-2925 200 mg Once Daily (QD) | 2 | |
| Overall Study | NOT COMPLETED | NYX-2925 50 mg QD | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | NYX-2925 200 mg QD | 0 | 75 | |
| other | Upper respiratory tract infection | Infections and infestations | NYX-2925 50 mg QD | 0 | 77 | |
| other | Upper respiratory tract infection | Infections and infestations | NYX-2925 10 mg QD | 4 | 77 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo QD | 0 | 72 | |
| other | Headache | Nervous system disorders | NYX-2925 200 mg QD | 1 | 75 | |
| other | Headache | Nervous system disorders | NYX-2925 50 mg QD | 1 | 77 | |
| other | Headache | Nervous system disorders | NYX-2925 10 mg QD | 4 | 77 | |
| other | Headache | Nervous system disorders | Placebo QD | 3 | 72 | |
| other | Diarrhoea | Gastrointestinal disorders | NYX-2925 200 mg QD | 1 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | NYX-2925 50 mg QD | 3 | 77 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NYX-2925 200 mg QD | 0 | 75 |
| Total, all-cause mortality | NYX-2925 50 mg QD | 0 | 77 |
| Total, all-cause mortality | NYX-2925 10 mg QD | 0 | 77 |
| Total, all-cause mortality | Placebo QD | 0 | 72 |
| Total, other adverse events | NYX-2925 200 mg QD | 3 | 75 |
| Total, other adverse events | NYX-2925 50 mg QD | 4 | 77 |
| Total, other adverse events | NYX-2925 10 mg QD | 12 | 77 |
| Total, other adverse events | Placebo QD | 4 | 72 |
| Total, serious adverse events | NYX-2925 200 mg QD | 0 | 75 |
| Total, serious adverse events | NYX-2925 50 mg QD | 0 | 77 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT03219320
GET https://conductscience.org/api/trials/v1/NCT03219320/events?page=2