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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: Completed Phase 2 study, sponsored by Trevi Therapeutics.
NCT03497975 is a Phase 2 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 353 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (165% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The NRS is a patient related outcome (PRO) instrument, designed to quantify the intensity of worst itching experienced during a 24-hour period, and can be applied and validated either with reference to the average itch or to the absolute worst itch (WI-NRS) over that 24-hour period. WI-NRS is a set of boxes, one for each number, from 0 (no itching) to 10 (worst possible itching). Higher scores indicate worst itching experience. Responder was defined as a participant with a ≥4-point decrease in t
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 |
What the finished NCT03497975 record still lists
NCT03497975 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (165% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Tablets is the first listed.
NCT03497975 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03497975's enrollment target sits among peer trials
353 129th of 2000 higher than 1,871 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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