Trial Outcomes & Findings for Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus (NCT NCT02143648)
NCT ID: NCT02143648
Last Updated: 2025-05-21
Results Overview
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
373 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
Nalbuphine HCl ER 60mg
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
|
Nalbuphine HCl ER 120mg
nalbuphine HCl ER tablets 120 mg BID
nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
|
Sugar Pill
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
120
|
125
|
|
Overall Study
COMPLETED
|
74
|
78
|
101
|
|
Overall Study
NOT COMPLETED
|
54
|
42
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Baseline characteristics by cohort
| Measure |
Nalbuphine HCl ER 60mg
n=126 Participants
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
|
Nalbuphine HCl ER 120mg
n=120 Participants
nalbuphine HCl ER tablets 120 mg BID
nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
|
Sugar Pill
n=123 Participants
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 8 weeks
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
308 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
Europe
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
69 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
97 participants
n=7 Participants
|
100 participants
n=5 Participants
|
300 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The sample sizes for each arm include participants who had a baseline value and at least one post baseline value for the average itch score during teh Evaluation Period.
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
Outcome measures
| Measure |
Nalbuphine HCl ER 60mg
n=82 Participants
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
|
Nalbuphine HCl ER 120mg
n=84 Participants
nalbuphine HCl ER tablets 120 mg BID
nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
|
Sugar Pill
n=108 Participants
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 8 weeks
|
|---|---|---|---|
|
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
|
-3.10 units on a scale
Standard Deviation 2.35
|
-3.49 units on a scale
Standard Deviation 2.37
|
-2.80 units on a scale
Standard Deviation 2.22
|
Adverse Events
Nalbuphine HCl ER 60mg
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Nalbuphine HCl ER 120mg
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 19 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nalbuphine HCl ER 60mg
n=126 participants at risk
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
|
Nalbuphine HCl ER 120mg
n=120 participants at risk
nalbuphine HCl ER tablets 120 mg BID
nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
|
Sugar Pill
n=123 participants at risk
Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 8 weeks
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
4/126
|
0.83%
1/120
|
0.00%
0/123
|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Cardiac disorders
Atrial flutter
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Cardiac disorders
Cardiac arrest
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Cardiac disorders
Cardiac tamponade
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Cardiac disorders
Right ventricular failure
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Cardiac disorders
Ventricular tachycardia
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.2%
4/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/126
|
0.83%
1/120
|
0.00%
0/123
|
|
Gastrointestinal disorders
Dyspepsia
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Gastrointestinal disorders
Gastritis
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Gastrointestinal disorders
Ilieus paralytic
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
2/126
|
0.83%
1/120
|
2.4%
3/123
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.79%
1/126
|
0.83%
1/120
|
1.6%
2/123
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Nervous system disorders
Transient ischemic attack
|
0.79%
1/126
|
0.83%
1/120
|
0.00%
0/123
|
|
Nervous system disorders
Convulsion
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Nervous system disorders
Sciatica
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Nervous system disorders
Syncope
|
0.00%
0/126
|
0.00%
0/120
|
1.6%
2/123
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/126
|
0.00%
0/120
|
1.6%
2/123
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
General disorders
Local swelling
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/126
|
0.83%
1/120
|
0.81%
1/123
|
|
Vascular disorders
Haemorrhage
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Vascular disorders
Hypotension
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Eye disorders
Vertigo
|
0.00%
0/126
|
0.83%
1/120
|
0.00%
0/123
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Infections and infestations
Gangrene
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Infections and infestations
Pneumonia
|
0.00%
0/126
|
0.00%
0/120
|
1.6%
2/123
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Infections and infestations
Sepsis
|
0.00%
0/126
|
0.00%
0/120
|
1.6%
2/123
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/126
|
0.83%
1/120
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.79%
1/126
|
0.00%
0/120
|
0.00%
0/123
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/126
|
0.83%
1/120
|
0.00%
0/123
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/126
|
0.00%
0/120
|
0.81%
1/123
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place