REVerse Intestinal Metaplasia in the Stomach (REVISE)
NCT06590454 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-02-12
Summary
This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment.
A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.
Conditions
- Gastric Intestinal Metaplasia
- Gastric Precancer
Interventions
- DRUG
-
Pyrvinium
Pyrvinium (2 mg/kg) per day for 14 days
- DRUG
-
Placebo for 14 days
Sponsors & Collaborators
-
Katherine Garman
lead OTHER
Principal Investigators
-
Katherine Garman, MD · Duke Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-15
- Primary Completion
- 2026-10-01
- Completion
- 2026-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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