A Phase 2/3 interventional study of nalbuphine HCl ER in Prurigo Nodularis, Nodularis Prurigo and Prurigo, sponsored by Trevi Therapeutics. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Trevi Therapeutics · Phase 2/3, Interventional, and Treatment
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.
38 studies on the registry are indexed under Prurigo; 10 are open to participants now.
This study's enrollment of 36 is below the median of 135 across 31 interventional studies indexed under Prurigo.
Browse Prurigo studies →Trevi Therapeutics is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
nalbuphine HCl ER
Drug: nalbuphine HCl ER
nalbuphine HCl ER BID for up to 50 weeks
Also known as: nalbuphine
Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: 50 weeks
| Milestone | Nalbuphine HCl ER |
|---|---|
| Started | 36 |
| Completed | 16 |
| Not completed | 20 |
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.
| Participants | Nalbuphine HCl ER |
|---|---|
| Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | 34 |
Collected over Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nalbuphine HCl ER | 0/36 (0%) | 2/36 (5.6%) | 0/36 (0%) |
| Event | Nalbuphine HCl ER |
|---|---|
| BradycardiaCardiac disorders | 1/36 |
| Joint injuryInjury, poisoning and procedural complications | 1/36 |
| Tenosynovitis stenosansMusculoskeletal and connective tissue disorders | 1/36 |
| Ulnocarpal abutment syndromeMusculoskeletal and connective tissue disorders | 1/36 |
| Age, Continuous(years) | Nalbuphine HCl ER |
|---|---|
| Mean | 52.4 ± 13.2 |
| Sex: Female, Male(Participants) | Nalbuphine HCl ER |
|---|---|
| Female | 16 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | Nalbuphine HCl ER |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 36 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nalbuphine HCl ER |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 33 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Nalbuphine HCl ER |
|---|---|
| United States | 5 |
| Europe | 31 |
| Height(cm) | Nalbuphine HCl ER |
|---|---|
| Mean | 172.33 ± 8.15 |
| Weight(kg) | Nalbuphine HCl ER |
|---|---|
| Mean | 79.68 ± 16.64 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nalbuphine