Trials / Completed
CompletedNCT03576235
Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Seoul National University Boramae Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with PG102P (1.5 g/day) and the other with a placebo. It is an investigator-initiated clinical trial. A superiority trial is planned to test the hypothesis that PG102P is effective in relieving pruritus for patients with ESRD undergoing HD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PG102P | Daily dose of 1.5g |
| DRUG | Placebo | Daily dose of placebo |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2019-01-31
- Completion
- 2019-03-30
- First posted
- 2018-07-03
- Last updated
- 2019-09-19
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03576235. Inclusion in this directory is not an endorsement.