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HMG-CoA reductase inhibitor

Quality-of-Life Assessment for Acute Pancreatitis

Phase 2
Waitlist Available
Led By Marc T Goodman
Research Sponsored by National Cancer Institute (NCI)
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 and 6 months
Awards & highlights

Study Summary

This trial looks at whether simvastatin can reduce pancreatitis in patients who have had it multiple times. Simvastatin may work by decreasing the inflammation of the pancreas.

Eligible Conditions
  • Acute Pancreatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Peak Bicarbonate Concentration, Measured Using Endoscopic Pancreatic Function Test (ePFT)
Secondary outcome measures
Change in Health-related Quality of Life.
Change in the Endoscopic Ultrasound Score (EUS)
Pancreatitis
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (simvastatin)Experimental Treatment4 Interventions
Patients receive simvastatin PO QD for 6 months.
Group II: Arm II (placebo)Placebo Group4 Interventions
Patients receive placebo PO QD for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,145 Total Patients Enrolled
Marc T GoodmanPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
132 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are joining this trial at present?

"This medical research trial is no longer accepting applicants. Initially posted on September 19th 2016, this study was most recently revised on December 7th 2021. Currently, there are 83 studies involving pancreatitis and 37 Quality-of-Life Assessment trials actively searching for patients to participate in their experimentations."

Answered by AI

Has a similar medical experiment been conducted prior to this one?

"At the present time, there are 37 ongoing studies examining Quality-of-Life Assessment in 239 cities and 31 countries that have been running since 2005. Merck Sharp & Dohme LLC initiated this research agenda with a Phase 4 drug approval stage involving 80 patients; these trials have accumulated 1032 participants over 15 years of data gathering."

Answered by AI

Has there been any precedent of Quality-of-Life Assessment studies?

"Quality-of-Life Assessment was initially trialled at OHSU Hospital in 2005, and presently there are 1032 completed studies. Currently 37 live clinical trials of this methodology exist, the majority held within Pittsburgh Pennsylvania."

Answered by AI

What health issues is Quality-of-Life Assessment typically employed to address?

"Quality-of-Life Assessment is a popular treatment plan for cholesterol, as well as diabetes Mellitus, cardiovascular event prevention and hypercholesterolemia."

Answered by AI

What goals are the researchers attempting to attain with this clinical experiment?

"This clinical trial's objective, evaluated over a period ranging from Baseline to up to 6 months, is to observe the alteration of peak bicarbonate concentration via endoscopic pancreatic function test (ePFT). Secondary outcomes include Pancreatitis-related Readmissions - specified as the number of patients with hospital readmission due to pancreatitis - as well as Serum and Pancreatic Secretions measured by fluorescent intensity for biomarkers such as HGF (hepatocyte growth factor), Resistin, and FASL (Fas ligand) in arbitrary units. Lastly, Change in serum and pancreatic secretions will be"

Answered by AI

What potential risks accompany Quality-of-Life Assessment for individuals?

"The Quality-of-Life Assessment received a score of 2 based on our team's evaluation because it is in Phase 2, signifying that some safety data has been collected but efficacy evidence is currently lacking."

Answered by AI

Does this investigation currently have capacity for new participants?

"At this time, no more patients are being accepted for the trial first posted on September 19th 2016. However, there are 83 pancreatitis studies and 37 Quality-of-Life Assessment trials actively recruiting participants."

Answered by AI

Are there multiple medical centers in this city conducting the research?

"The University of Pittsburgh Cancer Institute (UPCI), Cedars Sinai Medical Center, and Kaiser Permanente Los Angeles Medical Center are all participating in this clinical trial. Additionally, there are five other medical centres that have been approved to take part in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
2016. "Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02743364.
~1 spots leftby Apr 2025
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