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Can a Decades-Old drug reverse pancreatic scarring?

NCT ID NCT05551858

Disease control Sponsor: Georgetown University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether proglumide, an older drug that blocks a specific receptor, can safely reduce pain and slow or reverse the scarring seen in chronic pancreatitis. The study includes adults with confirmed chronic pancreatitis and compares proglumide against a placebo over 12 to 24 weeks. Researchers are checking safety, pain levels, and how well the pancreas functions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
proglumide (an oral drug that blocks the CCK-B receptor)
What this could lead to
If successful, this could lead to a new treatment that reduces pain and may slow or reverse pancreatic damage in chronic pancreatitis, potentially lowering cancer risk.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The drug's safety and effectiveness are still unproven, and it may not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Subjects are eligible with a history of chronic pancreatitis as defined by the Cambridge radiographic classification with abnormal pancreatic side branches but without main pancreatic duct obstructing calcifications. Inclusion Criteria: * Males or females age 18 to 75 years of age * Clinical symptoms of chronic pancreatitis * Plus confirmation of chronic pancreatitis with imaging (Cambridge classification), EUS, biopsy, or fecal elastase \<200µg/g, or abnormal 72 hr fecal fat and radiographic evidence of CP. * Pain not adequately controlled with medications * Pain of at least 5 on a numeric pain scale of 0-10 * Stable doses of anti-diabetic medication for at least 90 days prior to screening. * Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide). * Both males and females must be willing and able to continue contraception to prevent pregnancy for 3 months after the completion of the study. Exclusion Criteria: * Currently abusing alcohol (more than three drinks in a day or more than seven drinks per week) or nonprescription drugs * Pregnant or lactating, or unwilling to prevent pregnancy * Renal insufficiency; CKD; GFR\<60 * Unable to sign consent or maintain a diary * Liver enzymes \> 2x ULN, Hgb \<8.5, Creat\>2; HgbA1c\>8 * Type 1 Diabetes * Subjects with confirmed cirrhosis * Evidence of active gallbladder disease or gallbladder dyskinesia

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Conditions

The condition(s) this trial relates to.

chronic pancreatitis diabetes mellitus Pain pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain Pancreas fibrosis Safety issues

Contacts and locations

Locations

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.