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NCT05551858 · ClinicalTrials.gov registry record · Phase 1

Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis

A Phase 1 study of Pain and Safety Issues, sponsored by Georgetown University.

Active
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT05551858 is a Phase 1 study of Pain and Safety Issues that is active but no longer recruiting, run by Georgetown University. The registered enrollment target is 32 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05551858, a Phase 1 study of Pain and Safety Issues, is active but no longer recruiting, sponsored by Georgetown University.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

Chronic pancreatitis is a rare but debilitating condition associated with chronic abdominal pain, diarrhea, diabetes, and an 8-fold increased risk for the development of pancreatic cancer. Unfortunately, there is no available treatment to prevent the progression of chronic pancreatitis, and most subjects require narcotic medications to control the pain. A receptor protein call the CCK-B receptor becomes activated in chronic pancreatitis and is in part responsible for the scar tissue or fibrosis that occurs and responsible for the cancer risk. In mice with chronic pancreatitis, the inflammation and damage was reversed with an old drug called proglumide that blocks the activation of the CCK-B receptor. Proglumide has also been shown to possibly reduce pain. This protocol involved a 2-Part study to test the safety of oral proglumide in those with confirmed chronic pancreatitis and the second goal is to determine if proglumide improves pain and function of the pancreas. Part-1 is an open-labelled Lead-in Study of N=8 subjects over a 12-week treatment period. Part-2 is a randomized double blind pseudo cross over study where subjects will be treated in Arm A (placebo for 12 weeks followed by 12 weeks of proglumide) and Arm B ( proglumide for 24 weeks).

Interventions

  • DRUG Placebo
  • DRUG Proglumide

Study Locations (1)

District of Columbia

  • Georgetown University - Washington D.C.

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2022-11-17
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Georgetown University

227 total trials

What the Registry Record Tells You About NCT05551858

The ClinicalTrials.gov registry entry for NCT05551858 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (89% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05551858 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT05551858 about?

NCT05551858 is a clinical study titled "Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis". Chronic pancreatitis is a rare but debilitating condition associated with chronic abdominal pain, diarrhea, diabetes, and an 8-fold increased risk for the development of pancreatic cancer. Unfortunately, there is no available treatment to prevent the progression of chronic pancreatitis, and most sub...

What is the current status of trial NCT05551858?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-11-17. Estimated completion is 2026-12-31.

What conditions does trial NCT05551858 study?

This clinical trial studies the following conditions: Pain, Safety Issues, Pancreas Fibrosis.

What interventions are being tested in trial NCT05551858?

The interventions under investigation include: Placebo (DRUG), Proglumide (DRUG).

Who is sponsoring clinical trial NCT05551858?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05551858 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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