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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

Awards & highlights

ProCP Trial Summary

This trial is studying the side effects and best dose of proglumide in treating patients with chronic pancreatitis.

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.Check my eligibility

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.See study design

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.

ProCP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Change in blood chemistry tests

Secondary outcome measures

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

ProCP 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

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,470 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

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05551858 — Phase 1 & 2

Pain Research Study Groups: Placebo, Proglumide

Pain Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05551858 — Phase 1 & 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551858 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being recruited for this experiment?

"Data from clinicaltrials.gov show that this study is no longer recruiting patients for the trial. The first posting was on October 19th, 2022 and the last update was on October 3rd, 2022. There are 491 other trials that are currently seeking patients."

Answered by AI

Does this research project have an age limit?

"As this trial's inclusion requirements state, the minimum age for participation is 18 while the maximum is 75."

Answered by AI

Are there specific entry requirements for participants in this trial?

"This clinical trial is enrolling 32 patients who currently have pain and meet the following criteria: Males or females age 18 to 75 years of age, Clinical symptoms of chronic pancreatitis, Plus confirmation of chronic pancreatitis with imaging (Cambridge classification), EUS, biopsy, or fecal elastase <200µg/g, or abnormal 72 hr fecal fat and radiographic evidence of CP., Pain not adequately controlled with medications, Stable doses of anti-diabetic medication for at least 90 days prior to screening., Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD,"

Answered by AI