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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline mean scores on a scale of 1 to 5 will be compared to scores at 12 weeks and 24 weeks for reporting.

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

Do I qualify?Apply below to find out