Pruritus, Uremic Pruritus
Conditions
Keywords
Uremic, Pruritus, Itch, Chronic Itch, Nalbuphine
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 24 weeks.
Interventions
nalbuphine HCl ER
Sponsors
Trevi Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject completed participation in the TR02 study * Subject is currently receiving in-center hemodialysis at the time of consent
Exclusion criteria
* Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study * Subject received opiates on a daily basis during the 1 week prior to screening * Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening * Subject is a pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) | 24 weeks | The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nalbuphine HCl ER nalbuphine HCl ER | 167 |
| Total | 167 |
Baseline characteristics
| Characteristic | Nalbuphine HCl ER |
|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 89 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment Europe | 21 participants |
| Region of Enrollment United States | 146 participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 167 |
| other Total, other adverse events | 0 / 167 |
| serious Total, serious adverse events | 54 / 167 |
Outcome results
Primary
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nalbuphine HCl ER | Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) | 133 Participants |