Nodularis Prurigo, Prurigo, Prurigo Nodularis, Pruritus
Conditions
Keywords
Itch, Chronic Itch, nalbuphine
Brief summary
The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.
Interventions
DRUGnalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
DRUGnalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Placebo tablets BID administered for 10 weeks
Sponsors
Trevi Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject suffering from generalized prurigo nodularis * Have demonstrated pruritus intensity during screening * Male or female who are at least 18 years old at the time of consent
Exclusion criteria
* Subject has chronic pruritus resulting from other conditions * Subject has a history of substance abuse within the past year * Subject has a known drug allergy to opioids * Subject is a pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale | Baseline, Week 10 |
Other
| Measure | Time frame |
|---|---|
| Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale | Baseline, Week 10 |
Countries
Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nalbuphine HCl ER 90mg nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks | 22 |
| Nalbuphine HCl ER 180 mg nalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks | 18 |
| Sugar Pill Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 10 weeks | 22 |
| Total | 62 |
Baseline characteristics
| Characteristic | Sugar Pill | Total | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg |
|---|---|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 16.7 | 52.7 years STANDARD_DEVIATION 14.2 | 55.0 years STANDARD_DEVIATION 8.6 | 49.1 years STANDARD_DEVIATION 16.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 62 Participants | 22 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 54 Participants | 20 Participants | 15 Participants |
| Region of Enrollment Europe | 16 participants | 47 participants | 17 participants | 14 participants |
| Region of Enrollment United States | 6 participants | 15 participants | 5 participants | 4 participants |
| Sex: Female, Male Female | 12 Participants | 34 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 28 Participants | 10 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 18 | 0 / 22 |
| serious Total, serious adverse events | 1 / 22 | 0 / 18 | 1 / 22 |
Outcome results
Primary
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
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,
Time frame: Baseline, Week 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nalbuphine HCl ER 90mg | Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | 27.3 percentage of subjects |
| Nalbuphine HCl ER 180 mg | Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | 44.4 percentage of subjects |
| Sugar Pill | Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | 36.4 percentage of subjects |
Secondary
Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale
Time frame: Baseline, Week 10
Other Pre-specified
Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale
Time frame: Baseline, Week 10