A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCL ER Tablets in Prurigo Nodularis Patients

Trevi Therapeutics, Inc.0 sites60 target enrollmentAugust 29, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Trevi Therapeutics, Inc.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 29, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Trevi Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Individuals suffering from prurigo nodularis (PN) (definition: presence of pruritic nodules and/or papules due to chronic pruritus, i.e. pruritus and PN is actively present for at least 6 weeks prior to randomization).
•2\.Aged 18 years and older at the time of consent.
•3\.Generalized PN as defined as PN lesions involving two distinct anatomical areas: for example, either two limbs; or a single limb and some axial portion of the body. The subject is also eligible with only axial lesions with two distinct anatomical areas of involvement that have no peripheral nervous system overlap: for example, lesions involving a portion of the cranium and a portion of the trunk of the body. For purposes of this study, the axial portion is defined as any nonappendicular portion of the body.
•4\.NRS based worst itch (i.e., most severe) recorded daily over the 7 contiguous days prior to Visit 2 via daily electronic patient diary must have at least five measurements recorded. The mean value of the measurements must be \= 5\.
•Note: The last NRS value used in the calculation may be captured on the day of Visit 2\.
•5\. Males, non\-fecund females, or females of childbearing potential using an acceptable method of birth control (if sexually active). All females of childbearing potential must have a negative pregnancy test at the Screening and Baseline visits.
•For the purpose of this study, all females are considered to be of childbearing potential unless they are post\-menopausal (i.e., at least 1 year since last menses and age \>50 years) or surgically sterile (i.e., tubal ligation, hysterectomy and/or bilateral oophorectomy).
•Sexually active female patients of childbearing potential are required to use one barrier method (e.g., condom, cervical cap, or diaphragm) of contraception in addition to one other method (e.g., intrauterine device \[IUD] in place at least one month, stable hormonal contraception for at least 3 months, or tubal ligation, Essure procedure, or spermicide). For female patients using a barrier method plus spermicide, that method must be used for at least 14 days prior to screening. Female patients who are abstinent may participate in the study, however; they must be counseled on the requirement to use appropriate contraception should they become sexually active. This counseling should occur at each study visit and must be documented in source records.
•6\.Ability and acceptance to provide written informed consent.
•7\.Willing and able to comply with study requirements and restrictions

Exclusion Criteria

•1\. Chronic pruritus due the following conditions:
•Localized PN (only one localization affected, for example only on arms)
•Lichen amyloidosus
•Peripheral segmental neuropathic pruritus (such as notalgia paresthetica, brachioradial pruritus)
•2\. Active dermatoses in need of treatment (such as atopic dermatitis, bullous pemphigoid) that has not evolved into the diagnosis of prurigo nodularis or other dermatologic conditions that in the opinion of the Investigator could confound the ability to assess the NRS.
•3\. Major psychiatric disorder in the opinion of the Investigator that could interfere with the assessment of study drug, such as delusional parasitosis
•4\. Patients receiving treatment for human immunodeficiency virus (HIV) infection
•5\. Serum bilirubin \> 2\.5 times upper limit of normal (ULN) range at screening unless explained by a clinical diagnosis of Gilbert’s Syndrome
•6\. Serum hepatic alanine aminotransferase (AST) or aspartate aminotransferase (ALT) enzymes \> 2 times upper limit of normal (ULN) range at screening
•7\.Estimated glomerular filtration rate (eGFR) \= 44 mL/min/1\.73 m2 at Screening