Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

• Sponsor: Trevi Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02174432
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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 50 weeks.

Condition or Disease	Intervention/Treatment	Phase
Prurigo Nodularis; Nodularis Prurigo; Prurigo	Drug: nalbuphine HCl ER	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
• Actual Study Start Date: Aug 15, 2015
• Actual Primary Completion Date: Sep 3, 2017
• Actual Study Completion Date: Sep 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nalbuphine HCl ER nalbuphine HCl ER	Drug: nalbuphine HCl ER; nalbuphine HCl ER BID for up to 50 weeks; Other Names: nalbuphine

Outcome Measures

Primary Outcome Measures

1. Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) [50 weeks]

   Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject completed participation in the TR03 study

Exclusion Criteria:

• Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.

• Subject is a pregnant or lactating female

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Münster	Münster		Germany

Sponsors and Collaborators

• Trevi Therapeutics

Investigators

• Study Director: Thomas Sciascia, MD, Trevi Therapeutics

Study Documents (Full-Text)

• Statistical Analysis Plan - May 3, 2017
• Study Protocol - Jun 2, 2016

More Information

Publications

None provided.

• Responsible Party: Trevi Therapeutics
• ClinicalTrials.gov Identifier: NCT02174432
• Other Study ID Numbers: TR03ext; 2013-005628-41
• First Posted: Jun 25, 2014
• Last Update Posted: Oct 23, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Trevi Therapeutics: Itch; Chronic Itch; Nalbupine
• Additional relevant MeSH terms: Prurigo; Neurodermatitis; Nalbuphine

Study Results

Participant Flow

Arm/Group Title	Nalbuphine HCl ER
Arm/Group Description	nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Period Title: Overall Study
STARTED	36
COMPLETED	16
NOT COMPLETED	20

Baseline Characteristics

Arm/Group Title	Nalbuphine HCl ER
Arm/Group Description	nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.4 (13.2)
Sex: Female, Male (Count of Participants)
Female	16 44.4%
Male	20 55.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	36 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 5.6%
White	33 91.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	5 13.9%
Europe	31 86.1%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	172.33 (8.15)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	79.68 (16.64)

Outcome Measures

1. Primary Outcome

Title	Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)
Description	Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern.
Time Frame	50 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nalbuphine HCl ER
Arm/Group Description	nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Measure Participants	36
Count of Participants [Participants]	34 94.4%

Adverse Events

Time Frame	Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.
Arm/Group Title	Nalbuphine HCl ER
Arm/Group Description	nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
All Cause Mortality
	Nalbuphine HCl ER
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Serious Adverse Events
	Nalbuphine HCl ER
	Affected / at Risk (%)	# Events
Total	2/36 (5.6%)
Cardiac disorders
Bradycardia	1/36 (2.8%)
Injury, poisoning and procedural complications
Joint injury	1/36 (2.8%)
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans	1/36 (2.8%)
Ulnocarpal abutment syndrome	1/36 (2.8%)
Other (Not Including Serious) Adverse Events
	Nalbuphine HCl ER
	Affected / at Risk (%)	# Events
Total	0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.