Trial Outcomes & Findings for Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis (NCT NCT02174419)
NCT ID: NCT02174419
Last Updated: 2025-05-21
Results Overview
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,
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Baseline, Week 10
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Sugar Pill
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 10 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
22
|
|
Overall Study
COMPLETED
|
18
|
12
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
Baseline characteristics by cohort
| Measure |
Nalbuphine HCl ER 90mg
n=22 Participants
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
|
Nalbuphine HCl ER 180 mg
n=18 Participants
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
|
Sugar Pill
n=22 Participants
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 10 weeks
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 10The 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,
Outcome measures
| Measure |
Nalbuphine HCl ER 90mg
n=22 Participants
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
|
Nalbuphine HCl ER 180 mg
n=18 Participants
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
|
Sugar Pill
n=22 Participants
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 10 weeks
|
|---|---|---|---|
|
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
|
27.3 percentage of subjects
|
44.4 percentage of subjects
|
36.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, Week 10Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 10Outcome measures
Outcome data not reported
Adverse Events
Nalbuphine HCl ER 90mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Nalbuphine HCl ER 180 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nalbuphine HCl ER 90mg
n=22 participants at risk
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
|
Nalbuphine HCl ER 180 mg
n=18 participants at risk
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
|
Sugar Pill
n=22 participants at risk
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 10 weeks
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
4.5%
1/22
|
0.00%
0/18
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
4.5%
1/22
|
0.00%
0/18
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/22
|
0.00%
0/18
|
4.5%
1/22
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place