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

NCT ID: NCT02174432

Last Updated: 2025-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-15

Study Completion Date

2017-09-03

Brief Summary

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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.

Detailed Description

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Conditions

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Prurigo Nodularis Nodularis Prurigo Prurigo

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nalbuphine HCl ER

nalbuphine HCl ER

Group Type EXPERIMENTAL

nalbuphine HCl ER

Intervention Type DRUG

nalbuphine HCl ER BID for up to 50 weeks

Interventions

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nalbuphine HCl ER

nalbuphine HCl ER BID for up to 50 weeks

Intervention Type DRUG

Other Intervention Names

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nalbuphine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trevi Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chief Development Officer

Role: STUDY_DIRECTOR

Trevi Therapeutics

Locations

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University of Münster

Münster, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2013-005628-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TR03ext

Identifier Type: -

Identifier Source: org_study_id

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