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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: Active Phase 1 study of Pain and Safety Issues, sponsored by Georgetown University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Number of participants with abnormal chemistry blood tests at 12-weeks in placebo arm compared to treatment arm
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Proglumide
Study Locations (1)
District of Columbia
- Georgetown University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05551858 still lists
NCT05551858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05551858's enrollment target sits among peer trials
32 307th of 374 higher than 66 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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