Nodularis Prurigo, Prurigo, Prurigo Nodularis
Conditions
Keywords
Itch, Chronic Itch, Nalbupine
Brief summary
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.
Interventions
nalbuphine HCl ER BID for up to 50 weeks
Sponsors
Trevi Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject completed participation in the TR03 study
Exclusion criteria
* Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study. * Subject is a pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nalbuphine HCl ER nalbuphine HCl ER
nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Nalbuphine HCl ER |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 172.33 cm STANDARD_DEVIATION 8.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment Europe | 31 participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 20 Participants |
| Weight | 79.68 kg STANDARD_DEVIATION 16.64 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 2 / 36 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nalbuphine HCl ER | Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | 34 Participants |