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Enzyme Replacement Therapy

CREON for Chronic Pancreatitis

Phase 4
Waitlist Available
Research Sponsored by AbbVie
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 day 1 through day 85
Awards & highlights

Study Summary

This trial will assess whether there are differences in the way the body responds to Creon when it is the only source of the active drug, compared to when it is an alternate source.

Eligible Conditions
  • Chronic Pancreatitis
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptoms of Exocrine Pancreatic Insufficiency (EPI)

Side effects data

From 2014 Phase 3 trial • 41 Patients • NCT02137382
2%
Constipation
2%
Diarrhea
2%
Abdominal pain lower
2%
decreased appetite
2%
Gastric pH decreased
2%
hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creon N
Creon®

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Period: CreonExperimental Treatment1 Intervention
Participants will receive Creon daily for 112 days.
Group II: Run-in Period: CreonExperimental Treatment1 Intervention
Participants will receive Creon daily for 112 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CREON
2021
Completed Phase 4
~100

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
501,075 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,909 Total Patients Enrolled

Frequently Asked Questions

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

Could you provide insight into the health risks associated with CREON use?

"The potential danger associated with CREON was assessed at a 3 on the 1-3 scale, as it is already approved for use in Phase 4 trials."

Answered by AI

How extensive is the current participant base for this research endeavor?

"AbbVie will be conducting this medical trial, which requires 30 qualified participants. The two primary sites that have been selected to host the study are Univ Texas HSC San Antonio /ID# 239060 in San Antonio, TX and Wake Forest Baptist Health /ID# 229537 in Winston-Salem, NC."

Answered by AI

In what geographic areas is this research taking place?

"At present, 25 medical centers in the United States offer this clinical trial. Notable locations include San Antonio, Winston-Salem and Lebanon; however, there are 22 other sites you may find more convenient depending on your geographical location."

Answered by AI

Are there any enrollment opportunities currently available for this research endeavor?

"Clinicaltrials.gov suggests this medical study is currently accepting participants, with the initial post date being 14th of October 2021 and the latest changes made on 7th November 2022."

Answered by AI

Are there any precedential investigations concerning CREON?

"Currently, 7 clinical trials for CREON are active with 2 of those in Phase 3. Most of the studies related to this medication can be found around Mobile, Alabama; however, overall there are 53 trial sites across America participating in these assessments."

Answered by AI

Has this research been attempted before?

"At present, there are 7 active studies related to CREON that span 10 countries and 38 cities. The first one of these studies commenced in 2011 under the sponsorship of Boehringer Ingelheim. Originally enrolling 60 participants, this trial has since been followed by 57 others as it progresses through its drug approval stages."

Answered by AI

What medical conditions is CREON traditionally employed to treat?

"CREON has been prescribed to patients suffering from diarrhea, fat digestion issues, gastric resection and duodenal cancer."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Wake Forest Baptist Health /ID# 229537
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
2021. "Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05069597.
~9 spots leftby Apr 2025
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