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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 is a Phase 2 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 373 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02143648
The ClinicalTrials.gov registry entry for NCT02143648 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 373 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 3 interventions - of which Placebo tablets BID is the first listed.
NCT02143648 reports 0 study locations.
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.
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