Study of Nalbuphine HCl ER Tablets in Hemodialysis Patien... | NCT02143648

ID	Type	Description	Link
2013-005625-22	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nalbuphine HCl ER 60mg	Experimental	nalbuphine HCl ER tablets 60 mg BID	Drug: nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER 120mg	Experimental	nalbuphine HCl ER tablets 120 mg BID	Drug: nalbuphine HCl ER tablets 120mg BID
Sugar pill	Placebo Comparator	Placebo tablets BID	Drug: Placebo tablets BID

Name	Type	Description	Arm Group Labels	Other Names
nalbuphine HCl ER tablets 60 mg BID	Drug	nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks	nalbuphine HCl ER 60mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale	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.	8 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Chief Development Officer	Trevi Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nephrology Associates PC		Birmingham	Alabama	35211	United States
University South Alabama Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33283264	Derived	Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Nalbuphine HCl ER 120mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Sugar Pill	Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 8 weeks
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.0± 12.1 BG00155.2± 12.2 BG00256.5± 13.0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00058 BG00151 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00023 BG00120 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0012 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Europe

Title	Measurements
	BG00023 BG00123 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale

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.

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.

Posted

Least Squares Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	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
OG001	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
OG002	Sugar Pill	Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 8 weeks

Units	Counts
Participants	OG00082 OG00184 OG002108

Title

Denominators

Categories

Title	Measurements
	OG000-3.10± 2.35 OG001-3.49± 2.37 OG002-2.80± 2.22

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	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	126	16	126	126
EG001	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	120	8	120	120
EG002	Sugar Pill	Placebo tablets BID Placebo tablets BID: Placebo tablets BID administered for 8 weeks	123	19	123	123

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0004 affected126 at risk EG0011 affected120 at risk EG0020 affected123 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Cardiac tamponade	Cardiac disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Right ventricular failure	Cardiac disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0004 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected126 at risk EG0011 affected120 at risk EG0020 affected123 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Ilieus paralytic	Gastrointestinal disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected126 at risk EG0011 affected120 at risk EG0023 affected123 at risk
Fluid overload	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected126 at risk EG0011 affected120 at risk EG0022 affected123 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Transient ischemic attack	Nervous system disorders	Systematic Assessment	EG0001 affected126 at risk EG0011 affected120 at risk EG0020 affected123 at risk
Convulsion	Nervous system disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0022 affected123 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected126 at risk EG0010 affected120 at risk EG0022 affected123 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Local swelling	General disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 affected126 at risk EG0011 affected120 at risk EG0021 affected123 at risk
Haemorrhage	Vascular disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Vertigo	Eye disorders	Systematic Assessment	EG0000 affected126 at risk EG0011 affected120 at risk EG0020 affected123 at risk
Streptococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Gangrene	Infections and infestations	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Perirectal abscess	Infections and infestations	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0022 affected123 at risk
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0022 affected123 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected126 at risk EG0011 affected120 at risk EG0020 affected123 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected126 at risk EG0010 affected120 at risk EG0020 affected123 at risk
Conversion disorder	Psychiatric disorders	Systematic Assessment	EG0000 affected126 at risk EG0011 affected120 at risk EG0020 affected123 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected126 at risk EG0010 affected120 at risk EG0021 affected123 at risk

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C494814	BID protein, human
D000073893	Sugars