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Use of Pyrvinium to Reverse Stomach Precancerous Conditions

NCT06782048 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-17

No results posted yet for this study

Summary

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, to lower the chances of stomach cancer. Pyrvinium is a drug that has been used for a long time to treat pinworms in children and its anti-cancer properties are currently under investigation. Tests in animals have shown that pyrvinium made unhealthy tissue healthier and stopped some cells from growing in a bad way. Based on preclinical studies, the investigators hypothesise that the proportion of samples with pre-cancerous tissue in the stomach would decrease by 50% after exposure to pyrvinium at the 6-week timepoint, with anticipated durability of the response at the one-year follow-up.

Conditions

  • STOMACH NEOPLASM

Interventions

DRUG

Placebo

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

DRUG

Pyrvinium

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

PROCEDURE

Blood biomarkers analyses

Up to 20ml of blood will be drawn from each participant at each study visit, with a total of 4 study visits for molecular analyses.

PROCEDURE

Oesophagogastroduodenoscopy (OGD) and biopsy

Study participant will undergo OGD with collection of gastric mucosal biopsies at the baseline visit to ascertain IM status and for molecular analyses. Study participant will undergo follow-up gastroscopy with collection of gastric mucosal biopsies at day 7 of treatment, 6 weeks post-treatment and 1 year post-treatment to assess if endpoint is reached and for molecular analyses. Gastric juice samples will be collected during each OGD.

OTHER

Gastric juice, saliva and stool collection and analyses

Gastric juice will be taken, and gastric pH will be measured at each research endoscopy. Saliva and stool will also be obtained from participants at research endoscopy for microbiome studies at the following timepoints: baseline, 6 weeks post-treatment, and 1 year post-treatment.

Sponsors & Collaborators

  • National University of Singapore

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Singapore

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782048 on ClinicalTrials.gov