albuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritis
- Conditions
- remic Pruritis in Hemodialysis PatientsMedDRA version: 17.1Level: 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
- EUCTR2013-005626-29-RO
- Lead Sponsor
- Trevi Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 167
• Subject completed participation in the TR02 study
• Subject is currently receiving in-center hemodialysis at the time of consent
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 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
• Subject receiving or is anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
• Subject has received opiates on a daily basis during the 1 week prior to Screening
• Other than the TR02 Study Drug, subject received any investigational drug within 4 weeks prior to Screening.
• 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