Pyrvinium for Gastric Intestinal Metaplasia

(REVISE Trial)

Overseen By Laura Hayes, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Anticoagulants

Disqualifiers: Active gastric cancer, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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.

Research Team

Katherine Garman, MD

Principal Investigator

Duke Health

Eligibility Criteria

The REVISE trial is for individuals with gastric intestinal metaplasia, a condition where stomach lining cells change and have a higher risk of turning into cancer. Participants should show certain features that indicate an increased cancer risk.

Inclusion Criteria

I am over 18 and have a high-risk type of stomach condition with a family history of stomach cancer.

Ability to provide informed consent

Evidence of prior but not active H. pylori infection

Exclusion Criteria

I am at high risk of bleeding due to medication or a health condition.

I have been diagnosed with active gastric cancer.

Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person) for research-focused screening upper endoscopy

Treatment

Participants receive Pyrvinium or placebo by mouth once each day for a total of 14 days

2 weeks

Daily administration, 1 visit (in-person) for drug dispensing

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up endoscopy

4-8 weeks

1 visit (in-person) for follow-up endoscopy

Treatment Details

Interventions

• Pyrvinium

Trial Overview This study compares the effects of Pyrvinium, a potential treatment, against a placebo in reversing high-risk gastric intestinal metaplasia. The effectiveness will be measured by examining changes in the stomach's lining before and after treatment.

Participant Groups

Group I: Pyrvinium Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+