albuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritis
- Conditions
- remic Pruritis in Hemodialysis PatientsMedDRA version: 18.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-005625-22-PL
- Lead Sponsor
- Trevi Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
• Subject has been receiving in-center hemodialysis for = 3 months and are currently on a schedule of 3 times a week
• Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
• Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening.
• Have demonstrated pruritis intensity on the Itch NRS during Screening
• Male or female who are at least 18 years old at the time of Screening
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
• Subject had a significant alteration in dialysis regimen during the Screening Period
• Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
• Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
• Has had a history of substance abuse within 6 months prior to completing Screening.
• Subject has a known drug allergy to opioids
• Subject is a pregnant or lactating female
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method