REVerse Intestinal Metaplasia in the Stomach (REVISE)

NCT06590454 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: Pro00115397CA230416P2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 Precancer; Gastric Intestinal Metaplasia

Keywords

Gastric Intestinal Metaplasia; Pyrvinium

Outcome Measures

Primary Outcomes (1)

• Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia

  For the efficacy analysis, the investigators will primarily evaluate the change in the number of clinical biopsies with evidence of gastric intestinal metaplasia from the screening endoscopy to the follow-up endoscopy.

  Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)

Secondary Outcomes (5)

• Number of clinical biopsies with evidence of gastric intestinal metaplasia

  1 year

• Number of clinical biopsies with complete gastric intestinal metaplasia

  1 year

• Number of clinical biopsies with incomplete gastric intestinal metaplasia

  1 year

• Number of clinical biopsies with presence of parietal cells (reversal of atrophy)

  1 year

• Number of clinical biopsies with presence of inflammation

  1 year

Study Arms (2)

Pyrvinium

ACTIVE COMPARATOR

Participants will receive Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days.

Drug: Pyrvinium

Placebo

PLACEBO COMPARATOR

Participants will receive placebo by mouth once each day for a total of 14 days.

Drug: Placebo

Interventions

Pyrvinium DRUG

Pyrvinium (2 mg/kg) per day for 14 days

Pyrvinium

Placebo DRUG

Placebo for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer),
• Ability to provide informed consent,
• Evidence of prior but not active H. pylori infection

You may not qualify if:

• Active gastric cancer diagnosis,
• High-risk of bleeding complications due to anticoagulants or underlying medical condition,
• Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)

Sponsors & Collaborators

• Katherine Garman: lead

Study Sites (1)

Duke Health

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Interventions

pyrvinium

Study Officials

• Katherine Garman, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Pavlus

CONTACT

919-684-0311; nicole.pavlus@duke.edu

Laura Hayes, MS

CONTACT

919-684-8771; laura.hayes@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Randomized Controlled Trial: Pyrvinium (n=16) Placebo (n=16)

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)