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Proglumide for Chronic Pancreatitis (ProCP Trial)
Phase 1 & 2
Waitlist Available
Led By Jill P Smith, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline mean scores on a scale of 1 to 5 will be compared to scores at 12 weeks and 24 weeks
Summary
This trial tests proglumide, an older drug, to see if it can help people with chronic pancreatitis by blocking a protein that causes inflammation and pain. The study targets patients with severe symptoms and aims to reduce their pain and improve pancreatic function.
Who is the study for?
Adults aged 18-75 with confirmed chronic pancreatitis who experience significant pain despite medication can join. They must have stable diabetes treatment if applicable and agree to use contraception. Excluded are those with kidney issues, liver disease, anemia, gallbladder problems, type 1 diabetes, or substance abuse.
What is being tested?
The trial is testing Proglumide's safety and its ability to reduce pain and improve pancreatic function in chronic pancreatitis patients. It includes an initial open-label phase for eight subjects followed by a randomized double-blind phase with placebo and Proglumide treatments.
What are the potential side effects?
While the specific side effects of Proglumide aren't detailed here, participants may experience typical drug-related reactions such as digestive discomfort, allergic responses or exacerbation of existing symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline mean scores on a scale of 1 to 5 will be compared to scores at 12 weeks and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline mean scores on a scale of 1 to 5 will be compared to scores at 12 weeks and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events
Change in blood chemistry tests
Secondary study objectives
Change in Pain Measurements from baseline to end of treatment with proglumide compared to Placebo
Change in Pain Measurements numeric score from baseline to end of treatment with proglumide compared to Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProglumideExperimental Treatment1 Intervention
Proglumide therapy 400 mg by mouth three times daily for 12 weeks in a blinded fashion followed by continued proglumide 400 mg by mouth three times daily for 12 additional weeks in an open labeled fashion. Hence this arm receives proglumide for a total of 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Arm 1. Placebo for first 12 weeks. Placebo is a fiber filler called Avicel and is given by mouth three times daily.
Note: After 12 weeks on placebo, these subjects will receive proglumide 400 mg orally three times daily open labeled for 12 additional weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proglumide
2019
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
136,987 Total Patients Enrolled
1 Trials studying Pain
15 Patients Enrolled for Pain
Jill P Smith, MDPrincipal InvestigatorGeorgetown University
4 Previous Clinical Trials
47 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pain is not well-managed with my current medications.I have Type 1 Diabetes.I am between 18 and 75 years old.I have ongoing symptoms of pancreatitis.My diabetes medication dose has been the same for the last 3 months.My pain level is 5 or higher on a scale of 0 to 10.My tests confirm I have chronic pancreatitis.I have been diagnosed with cirrhosis.I am using effective birth control or am not able to have children.My kidney function is reduced with a GFR below 60.I have an active gallbladder condition.I agree to use birth control for 3 months after the study ends.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Proglumide
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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