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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Pyrvinium to determine its effectiveness in treating gastric intestinal metaplasia, a stomach condition that can increase cancer risk. Participants will receive either Pyrvinium or a placebo (a harmless pill with no active ingredients) to compare effects. Researchers will examine changes in the stomach lining before and after treatment. Adults with a known diagnosis of gastric intestinal metaplasia and a family history of stomach cancer, but no active stomach cancer, might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that Pyrvinium is likely to be safe for humans?

Research has shown that Pyrvinium has been safely used for over 70 years to treat intestinal pinworms. The FDA has approved it, indicating well-documented safety. In past studies, Pyrvinium was tested on people for similar conditions and was generally well-tolerated, with most participants not experiencing serious side effects. This current trial is in the early stages and primarily focuses on assessing the safety and effectiveness of Pyrvinium for treating gastric intestinal metaplasia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike conventional treatments for gastric intestinal metaplasia, which often focus on lifestyle changes or monitoring progression to more severe conditions, Pyrvinium offers a new approach by using an active ingredient originally known for its antiparasitic effects. Researchers are excited about Pyrvinium because it targets the specific cellular pathways involved in the development of intestinal metaplasia, potentially halting or reversing the condition. Additionally, Pyrvinium is administered orally and may demonstrate noticeable effects in just 14 days, offering a faster and more direct treatment option compared to current standards.

What evidence suggests that Pyrvinium might be an effective treatment for gastric intestinal metaplasia?

Research has shown that pyrvinium, which participants in this trial may receive, may help treat gastric intestinal metaplasia, a condition that can lead to stomach cancer. Studies have found that pyrvinium can prevent this condition from worsening and can help change pre-cancerous cells back into healthy stomach lining. It targets specific stem cells involved in these harmful changes. Early results suggest that pyrvinium could help the stomach lining heal and grow back normally. This makes pyrvinium a promising option for preventing stomach cancer by reversing early, dangerous changes in the stomach. ^{1 2 5 6 7}

Who Is on the Research Team?

Katherine Garman, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

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

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

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

I have been diagnosed with active gastric cancer.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Katherine Garman

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06782048

NCT06782048 | Use of Pyrvinium to Reverse Stomach ... This study is carried out to find out if a drug called pyrvinium is able to convert pre-cancerous tissue in the stomach back to healthy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841458/

Targeting Stem Cells and Dysplastic Features with Dual ... These results suggest that Pyrvinium effectively inhibits metaplasia progression to dysplasia and promotes the regeneration of normal gastric ...

3. ecancer.org ecancer.org/en/news/23803-study-validates-pyrvinium-as-treatment-to-prevent-stomach-cancer

Study validates pyrvinium as treatment to prevent stomach ... “Our study suggests that pyrvinium can lead to mucosal recovery from metaplastic and/or dysplastic to normal by targeting a stem cell population ...

4. clinicaltrial.be clinicaltrial.be/en/details/451545?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

REVerse Intestinal Metaplasia in the Stomach (REVISE) - C... Following the initial endoscopy, participants will receive placebo or Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. The ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/567038

Use of Pyrvinium to Reverse Stomach Precancerous Conditions This study is carried out to find out if a drug called pyrvinium is able to convert pre-cancerous tissue in the stomach back to healthy tissue, ...

6. ctv.veeva.com ctv.veeva.com/study/reverse-intestinal-metaplasia-in-the-stomach-revise

REVerse Intestinal Metaplasia in the Stomach (REVISE) 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 ...

7. news.vumc.org news.vumc.org/2023/10/05/study-validates-pyrvinium-as-treatment-to-prevent-stomach-cancer/

Study validates pyrvinium as treatment to prevent stomach ... Pyrvinium has been used for over 70 years for intestinal pinworms and has a known safety profile.