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NCT02174419 · ClinicalTrials.gov registry record · Phase 2
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
A Phase 2 study of Prurigo Nodularis and Pruritus, sponsored by Trevi Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 4
- Study locations
NCT02174419: Completed Phase 2 study of Prurigo Nodularis and Pruritus, sponsored by Trevi Therapeutics.
NCT02174419 is a Phase 2 study of Prurigo Nodularis and Pruritus that has completed, run by Trevi Therapeutics. The registered enrollment target is 62 participants, below the 225-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (72% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02174419, a Phase 2 study of Prurigo Nodularis and Pruritus, has completed, sponsored by Trevi Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objectives of the study are 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 patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.
Primary Outcome
The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,
Conditions Studied
Interventions
- DRUG nalbuphine HCl ER tablets 90 mg BID
- DRUG nalbuphine HCl ER tablets 180 mg BID
- DRUG Placebo tablets BID
Study Locations (4)
Ohio
- Case Western Reserve University - Cleveland
Pennsylvania
- Temple University Hospital - Philadelphia
Other
- University of Münster - Münster
Lower Silesian Voivodeship
- Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu - Wroclaw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT02174419 record still lists
NCT02174419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 225-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (72% lower).
The record links to 4 conditions, with Prurigo Nodularis appearing as the primary indexed condition, and to 3 interventions - of which nalbuphine HCl ER tablets 90 mg BID is the first listed.
NCT02174419 reports a single indexed study location in Ohio, Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT02174419 about?
NCT02174419 is a clinical study titled "Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis". The primary objectives of the study are 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 patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.
What is the current status of trial NCT02174419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2015-03. Estimated completion is 2016-08.
What conditions does trial NCT02174419 study?
This clinical trial studies the following conditions: Prurigo Nodularis, Pruritus, Nodularis Prurigo, Prurigo.
What interventions are being tested in trial NCT02174419?
The interventions under investigation include: nalbuphine HCl ER tablets 90 mg BID (DRUG), nalbuphine HCl ER tablets 180 mg BID (DRUG), Placebo tablets BID (DRUG).
Who is sponsoring clinical trial NCT02174419?
This trial is sponsored by Trevi Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02174419 being conducted?
This trial has 4 study locations across Ohio, Pennsylvania, Lower Silesian Voivodeship. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02174419's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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