albuphine HCL ER Tablets in Prurigo Nodularis Patients

Phase 1

• Conditions: Prurigo Nodularis; MedDRA version: 19.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-005627-17-AT
• Lead Sponsor: Trevi Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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
8.Agree to the confidential use and storage of all data (including photography) and use of all anonymized data for publication including scientific publication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 Sscreening
8. Use of the following medications:
• topical antihistamines (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• topical capsaicin (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• topical calcineurin inhibitors (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• topical antibiotics (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• topical steroids (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• antiseptic bathes and anti-septic cleansing lotions (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• systemic antihistamines (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• anti-convulsant class drugs (4 weeks prior to e-diary NRS and VRS collection during the Screening period);
• systemic steroids (4 weeks prior to e-diary NRS and VRS collection during the Screening period);
• naltrexone or naloxone (4 weeks prior to e-diary NRS and VRS collection during the Screening period);
• cyclosporin A and other immunosuppressants (4 weeks prior to e-diary NRS and VRS collection during the Screening period);
• antidepressant medications (4 weeks prior to e-diary NRS and VRS collection during the Screening period);
• benzodiazepine class drugs (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
• neuroleptic class drugs (2 weeks prior to e-diary NRS and VRS collection during the Screening period);
NOTE: During washout of excluded medications, rescue is permitted with cleansing lotion or pure emollients (emollients without active substances such as menthol, urea, etc.)
9.UV-therapy (PUVA, UVA, UVB, Excimer) (4 weeks prior to e-diary NRS and VRS collection during the Screening period).
10. Patients who received opiates within 14 days prior to e-diary NRS and VRS collection during the Screening period.
11. Patients with a history of congestive heart failure of Class 2 or higher as graded using the New York Heart Association scale (scale provided in Appendix 5)
12. Patients with a history of angina pectoris grade 2 or higher as graded using the Canadian Cardiovascular Society grading scale (scale provided in Appendix 5)
13. History of ventricular tachycardia, torsade de pointes, family histor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified