Trial · NCT02174419
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
NCT02174419, Phase 2, Phase 3, Completed, Trevi Therapeutics; results first posted 2020-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis. Trials, record NCT02174419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02174419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
- NCT number
- NCT02174419
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- Trevi Therapeutics
- Conditions
- Prurigo Nodularis, Nodularis Prurigo, Prurigo, Pruritus
- Interventions
- nalbuphine HCl ER tablets 90 mg BID, nalbuphine HCl ER tablets 180 mg BID, Placebo tablets BID
- First posted
- 2014-06-25
- Last updated
- 2025-05-21
- Other registries' IDs
- eudract:2013-005627-17
- Results first posted
- 2020-08-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | Baseline, Week 10 | The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated, |
| Secondary | Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale | Baseline, Week 10 | |
| Other | Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale | Baseline, Week 10 |
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 | Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | Baseline, Week 10 | percentage of subjects | NUMBER | |
| SECONDARY | Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale | Baseline, Week 10 | |||
| OTHER_PRE_SPECIFIED | Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale | Baseline, Week 10 |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | Nalbuphine HCl ER 90mg | 27.3 | percentage of subjects | ||
| Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | Nalbuphine HCl ER 180 mg | 44.4 | percentage of subjects | ||
| Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | Sugar Pill | 36.4 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nalbuphine HCl ER 90mg | 22 | |
| Overall Study | STARTED | Nalbuphine HCl ER 180 mg | 18 | |
| Overall Study | STARTED | Sugar Pill | 22 | |
| Overall Study | COMPLETED | Nalbuphine HCl ER 90mg | 18 | |
| Overall Study | COMPLETED | Nalbuphine HCl ER 180 mg | 12 | |
| Overall Study | COMPLETED | Sugar Pill | 20 | |
| Overall Study | NOT COMPLETED | Nalbuphine HCl ER 90mg | 4 | |
| Overall Study | NOT COMPLETED | Nalbuphine HCl ER 180 mg | 6 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 2 |
Source ClinicalTrials.gov
Adverse events9
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 | Road traffic accident | Injury, poisoning and procedural complications | Nalbuphine HCl ER 90mg | 1 | 22 | |
| serious | Road traffic accident | Injury, poisoning and procedural complications | Nalbuphine HCl ER 180 mg | 0 | 18 | |
| serious | Road traffic accident | Injury, poisoning and procedural complications | Sugar Pill | 0 | 22 | |
| serious | Thoracic vertebral fracture | Injury, poisoning and procedural complications | Nalbuphine HCl ER 90mg | 1 | 22 | |
| serious | Thoracic vertebral fracture | Injury, poisoning and procedural complications | Nalbuphine HCl ER 180 mg | 0 | 18 | |
| serious | Thoracic vertebral fracture | Injury, poisoning and procedural complications | Sugar Pill | 0 | 22 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Nalbuphine HCl ER 90mg | 0 | 22 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Nalbuphine HCl ER 180 mg | 0 | 18 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Sugar Pill | 1 | 22 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nalbuphine HCl ER 90mg | ||
| Total, all-cause mortality | Nalbuphine HCl ER 180 mg | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Nalbuphine HCl ER 90mg | 0 | 22 |
| Total, other adverse events | Nalbuphine HCl ER 180 mg | 0 | 18 |
| Total, other adverse events | Sugar Pill | 0 | 22 |
| Total, serious adverse events | Nalbuphine HCl ER 90mg | 1 | 22 |
| Total, serious adverse events | Nalbuphine HCl ER 180 mg | 0 | 18 |
| Total, serious adverse events | Sugar Pill | 1 | 22 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT02174419
GET https://conductscience.org/api/trials/v1/NCT02174419/registered