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NCT02143648 · ClinicalTrials.gov registry record · Phase 2
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
A Phase 2 study, sponsored by Trevi Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 373
- Enrollment target
NCT02143648: Completed Phase 2 study, sponsored by Trevi Therapeutics.
NCT02143648 is a Phase 2 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 373 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02143648, a Phase 2 study, has completed, sponsored by Trevi Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 373 participants
- Enrollment target
Study Summary
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.
Primary Outcome
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
Interventions
- DRUG Placebo tablets BID
- DRUG nalbuphine HCl ER tablets 60 mg BID
- DRUG nalbuphine HCl ER tablets 120mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT02143648 record still lists
NCT02143648 is an interventional study that assigns participants to a tested intervention. The registered 373 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 (180% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo tablets BID is the first listed.
NCT02143648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02143648 about?
NCT02143648 is a clinical study titled "Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus". The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study p...
What is the current status of trial NCT02143648?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 373 participants. The study started on 2014-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02143648?
The interventions under investigation include: Placebo tablets BID (DRUG), nalbuphine HCl ER tablets 60 mg BID (DRUG), nalbuphine HCl ER tablets 120mg BID (DRUG).
Who is sponsoring clinical trial NCT02143648?
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 NCT02143648's enrollment target sits among peer trials
373 118th of 2000 higher than 1,883 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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