PRISM Study-Pruritus Relief Through Itch Scratch Modulation
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03497975
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 353 participants
Conditions and interventions
Conditions
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 7, 2018 (Actual)
- Primary completion
- May 10, 2022 (Actual)
- Completion
- Feb 24, 2023 (Actual)
- Last update posted
- Jun 24, 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 24, 2025 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03497975 live on ClinicalTrials.gov.