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NCT03497975 · ClinicalTrials.gov registry record · Phase 2
PRISM Study-Pruritus Relief Through Itch Scratch Modulation
A Phase 2 study, sponsored by Trevi Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 353
- Enrollment target
NCT03497975 is a Phase 2 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 353 participants.
The verdict
NCT03497975, a Phase 2 study, has completed, sponsored by Trevi Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 353 participants
- Enrollment target
Study Summary
To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets in Prurigo Nodularis. Participants were randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, participants who received NAL ER were continued on NAL ER and participants who received placebo would then shift to NALER.
Interventions
- DRUG Placebo Tablets
- DRUG Nalbuphine ER Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2018-08-07 |
| Est. Completion | 2023-02-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03497975
The ClinicalTrials.gov registry entry for NCT03497975 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Trevi Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Tablets is the first listed.
NCT03497975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03497975 about?
NCT03497975 is a clinical study titled "PRISM Study-Pruritus Relief Through Itch Scratch Modulation". To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets in Prurigo Nodularis. Participants were randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, participants who received NAL...
What is the current status of trial NCT03497975?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 353 participants. The study started on 2018-08-07. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT03497975?
The interventions under investigation include: Placebo Tablets (DRUG), Nalbuphine ER Tablets (DRUG).
Who is sponsoring clinical trial NCT03497975?
This trial is sponsored by Trevi Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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