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

Study acronym: ProCP
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years later Jun 30, 2026 → Jun 30, 2030
See other at-risk trials from Georgetown University

Record History

  1. Primary completion pushed from Jun 30, 2026 to Jun 30, 2030 Completion pushed from Dec 31, 2026 to Dec 31, 2031 · Publications: 1 to 2v7 Show 2 more changesShow less
    • Completion pushed from Dec 31, 2026 to Dec 31, 2031
    • Publications: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  3. 2 versions Re-verified since Dec 1, 2022, no change to tracked fieldsv4-v5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 19, 2022 to Nov 17, 2022 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Oct 19, 2022 to Nov 17, 2022
    • Site details revised
  5. Start date: Sep 19, 2022 to Oct 19, 2022v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05551858
Lead Sponsor Georgetown University
Conditions Safety Issues, Pain, Pancreas Fibrosis
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov