Gastric Intestinal MetaplasiaPhase 2REVISENCT06590454
REVerse Intestinal Metaplasia in the Stomach (REVISE)
A Phase 2 study testing Pyrvinium in people with Gastric Intestinal Metaplasia and Gastric Precancer, run by Katherine Garman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Intestinal Metaplasia, Gastric Precancer
- What is being tested?
- Pyrvinium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 1 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Health
Durham, North Carolina, 27710
Christy Walters, RN, 919-668-5499, christy.walters@duke.edu
Katherine Garman, MD
About this study
Official title: Therapeutic Intervention to Reverse Gastric Precancer
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.
Read the detailed description
The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). This initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines for mapping and surveillance). The investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping, and then of these 60 participants, 32 eligible participants (after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia) will be included in the randomized control trial to receive either Pyrvinium (n=16) or placebo (n=16).
Treatment is planned as followed:
2 weeks of Pyrvinium vs placebo (within 3 months of initial research endoscopy).
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 drug (or placebo) will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff. The drug and placebo will be administered as liquid suspensions. Medication diary logs will be used and participants will be asked to return bottles that contained the medication.
All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity.
- Conditions
- Gastric Intestinal Metaplasia, Gastric Precancer
- Being tested
- Pyrvinium, Placebo
- Keywords
- Gastric Intestinal Metaplasia, Pyrvinium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrviniumDrug
Pyrvinium (2 mg/kg) per day for 14 days
PlaceboDrug
Placebo for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Pyrvinium | Active comparator | Participants will receive Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. Receives: Drug: Pyrvinium |
| Placebo | Placebo comparator | Participants will receive placebo by mouth once each day for a total of 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)
Secondary outcomes (5)
Number of clinical biopsies with evidence of gastric intestinal metaplasia
Measured: 1 year
Number of clinical biopsies with complete gastric intestinal metaplasia
Measured: 1 year
Number of clinical biopsies with incomplete gastric intestinal metaplasia
Measured: 1 year
Number of clinical biopsies with presence of parietal cells (reversal of atrophy)
Measured: 1 year
Number of clinical biopsies with presence of inflammation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Dec 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial: Pyrvinium (n=16) Placebo (n=16)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katherine Garman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katherine Garman, Duke University
- Investigators
- Katherine Garman, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590454
- Sponsor's protocol ID
- Pro00115397
- Other IDs
- CA230416P2
- Acronym
- REVISE
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Intervention to Reverse Gastric Precancer
- ClinicalTrials.gov ID
- NCT06590454
- Acronym / sponsor ID
- REVISE / Pro00115397
- Conditions
- Gastric Intestinal Metaplasia, Gastric Precancer
- Keywords
- Gastric Intestinal Metaplasia, Pyrvinium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Katherine GarmanUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). This initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines for mapping and surveillance). The investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping, and then of these 60 participants, 32 eligible participants (after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia) will be included in the randomized control trial to receive either Pyrvinium (n=16) or placebo (n=16).
Treatment is planned as followed:
2 weeks of Pyrvinium vs placebo (within 3 months of initial research endoscopy).
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 drug (or placebo) will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff. The drug and placebo will be administered as liquid suspensions. Medication diary logs will be used and participants will be asked to return bottles that contained the medication.
All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial: Pyrvinium (n=16) Placebo (n=16)
| Arm | Type | Receives |
|---|---|---|
| Pyrvinium | Active comparator | Drug: PyrviniumParticipants will receive Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo by mouth once each day for a total of 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrviniumPyrvinium (2 mg/kg) per day for 14 days | Drug | Pyrvinium |
| PlaceboPlacebo for 14 days | Drug | Placebo |
Primary outcome
Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia
Time frame: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)
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.
5 secondary outcomes
Number of clinical biopsies with evidence of gastric intestinal metaplasia
Time frame: 1 year
Number of clinical biopsies with complete gastric intestinal metaplasia
Time frame: 1 year
Number of clinical biopsies with incomplete gastric intestinal metaplasia
Time frame: 1 year
Number of clinical biopsies with presence of parietal cells (reversal of atrophy)
Time frame: 1 year
Number of clinical biopsies with presence of inflammation
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Garman, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrvinium in people with Gastric Intestinal Metaplasia and Gastric Precancer, run by Katherine Garman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Pavlus (919-684-0311, nicole.pavlus@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia (time frame: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.