Trial · NCT02174432
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
NCT02174432, Phase 2, Phase 3, Completed, Trevi Therapeutics; results first posted 2020-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis. Trials, record NCT02174432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02174432
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
- NCT number
- NCT02174432
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- Trevi Therapeutics
- Conditions
- Prurigo Nodularis, Nodularis Prurigo, Prurigo
- Interventions
- nalbuphine HCl ER
- First posted
- 2014-06-25
- Last updated
- 2025-05-21
- Other registries' IDs
- eudract:2013-005628-41
- Results first posted
- 2020-10-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | 50 weeks | Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | 50 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | Nalbuphine HCl ER | 34 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nalbuphine HCl ER | 36 | |
| Overall Study | COMPLETED | Nalbuphine HCl ER | 16 | |
| Overall Study | NOT COMPLETED | Nalbuphine HCl ER | 20 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Bradycardia | Cardiac disorders | Nalbuphine HCl ER | 1 | 36 | |
| serious | Joint injury | Injury, poisoning and procedural complications | Nalbuphine HCl ER | 1 | 36 | |
| serious | Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | Nalbuphine HCl ER | 1 | 36 | |
| serious | Ulnocarpal abutment syndrome | Musculoskeletal and connective tissue disorders | Nalbuphine HCl ER | 1 | 36 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nalbuphine HCl ER | 0 | 36 |
| Total, other adverse events | Nalbuphine HCl ER | 0 | 36 |
| Total, serious adverse events | Nalbuphine HCl ER | 2 | 36 |
Source ClinicalTrials.gov
Papers0
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/NCT02174432
GET https://conductscience.org/api/trials/v1/NCT02174432/registered