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Completed Phase 2Phase 3 Interventional Results available

PRISM Study-Pruritus Relief Through Itch Scratch Modulation

ClinicalTrials.gov ID: NCT03497975

Public ClinicalTrials.gov record NCT03497975. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

Study identification

NCT ID
NCT03497975
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Trevi Therapeutics
Industry
Enrollment
353 participants

Conditions and interventions

Interventions

  • Nalbuphine ER Tablets Drug
  • Placebo Tablets Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 6, 2018
Primary completion
May 9, 2022
Completion
Feb 23, 2023
Last update posted
Jun 23, 2025

2018 – 2023

United States locations

U.S. sites
36
U.S. states
22
U.S. cities
35
Facility City State ZIP Site status
Study Site 151 Phoenix Arizona 85006
Study Site 121 Fremont California 94538
Study Site 157 Laguna Niguel California 92677
Study Site 141 North Hollywood California 91606
Study Site 130 San Francisco California 94115
Study Site 128 Washington D.C. District of Columbia 20037
Study Site 138 Boca Raton Florida 33433
Study Site 158 Orlando Florida 32819
Study Site 108 South Miami Florida 33143
Study Site 142 Tampa Florida 33615
Study Site 102 Rockville Maryland 20850
Study Site 136 Boston Massachusetts 02114
Study Site 153 Brighton Massachusetts 02135
Study Site 143 Ann Arbor Michigan 48103
Study Site 139 Troy Michigan 48084
Study Site 118 Saint Joseph Missouri 64506
Study Site 144 Henderson Nevada 89052
Study Site 146 Las Vegas Nevada 89119
Study Site 109 Portsmouth New Hampshire 03801
Study Site 159 Hackensack New Jersey 07601
Study Site 134 Stony Brook New York 11794
Study Site 101 Wilmington North Carolina 28411
Study Site 122 Cincinnati Ohio 45219
Study Site 120 Cleveland Ohio 44106
Study Site 132 Hershey Pennsylvania 17033
Study Site 106 Philadelphia Pennsylvania 19103
Study Site 131 Johnston Rhode Island 02919
Study Site 147 Charleston South Carolina 29407
Study Site 107 Charleston South Carolina 29425-8908
Study Site 140 Chattanooga Tennessee 37421
Study Site 145 Knoxville Tennessee 37917
Study Site 137 Austin Texas 78705
Study Site 103 Webster Texas 77598
Study Site 150 West Jordan Utah 84088
Study Site 135 Spokane Washington 99202
Study Site 148 Morgantown West Virginia 26505

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03497975, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 23, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03497975 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →