Clinical Trials
When you participate in a clinical trial you help pave the way for new treatments.
What is a clinical trial?
A clinical trial is a research study to test new treatments on people. It is a critical step in the process of getting a new treatment approved so that it can be given to patients. After a drug is thoroughly tested in a lab, a clinical trial is designed to test it and make sure that it is effective and safe in humans, and has the desired effect on the condition it is intended to treat. Many drugs never get off the ground because there are not enough volunteers. Don’t let that happen with new pancreatitis treatments. You have the power to propel research and development toward a cure! Learn more about what is involved in these pancreatitis clinical trials to see if they are right for you.
meTriG Study
If you have triglycerides at or above 500 mg/dL, you may be eligible to join a 6-month, at-home, app-based research study! Participants will be compensated up to $360 in gift cards for completing study activities.
The meTriG Study collects everyday health observations from people living with triglycerides at or above 500 mg/dL. Participants will use the Folia Health app to collect real-time info on treatment use and symptoms. By spending just 90 seconds a day tracking the things you notice about your health, you’ll help researchers understand the day-to-day experience of living with high triglycerides.
For more information, visit www.foliahealth.com/metrigstudy. Use invite code MC500 to sign up.
STTEPP
Dr. Fogel and his colleagues at IU hope that repurposing lacosamide in combination with opioid therapy will improve the quality of life of those suffering from chronic pancreatitis while decreasing opioid use.
This is an NIH-funded phase 1 trial, “Safety, Tolerability and dose-limiting Toxicity of lacosamide in patients with Painful chronic Pancreatitis (STTEPP)”. Opioid-induced hyperalgesia (OIH) may occur with opioid therapy, a phenomenon resulting in dose escalation. Lacosamide, an antiseizure drug, may inhibit the effects of OIH. This may result in improved pain control with a decrease in opioid use. In trials with neuropathic pain, lacosamide reduced pain scores and was well tolerated. There are no data, however, evaluating the use of lacosamide in patients with chronic pancreatitis.
To learn more about the clinical trial and see if it is right for you, contact:
Evan L Fogel, MD, MSc
317-944-2816
efogel@iu.edu
Fletcher A White, MS, PhD
317-274-5164
fawhite@iu.edu
ALLIANCE
Paricalcitol (also known as Zemplar) is a prescription form of vitamin D, currently used to treat chronic kidney disease. Paricalcitol works by reducing hormone levels in the parathyroid and helps the body better absorb calcium and phosphorus. Dr. Stephen Pandol and his colleagues at Cedars-Sinai Medical Center hope that paricalcitol will improve the quality of life of those suffering from chronic pancreatitis and slow disease progression.
The goal of the clinical trial is to test the safety and effectiveness of paricalcitol in people with chronic pancreatitis. The study also aims to improve symptoms and reduce the pain of chronic pancreatitis.
Participants must be able to travel to Cedars-Sinai Medical Center in Los Angeles 4 times over the course of a year. Testing procedures will be conducted in L.A. and may include blood tests, questionnaires, and the review of medical records. Participants will either receive a “placebo” pill once daily for 12 months, or they will receive paricalcitol for 12 months. To learn more about the clinical trial and see if it is right for you, contact Marissa Podell by calling (310) 967-1109 or emailing marissa.podell@cshs.org.
The ExoLuminate Study
Researchers at Biological Dynamics want to test how a new technology can help detect cancer earlier in patients who are at risk of pancreatic cancer. To participate, all you’ll need to do is get your blood drawn – at no cost to you – up to three times, either at your neighborhood lab or at your home with the study’s mobile health team.
You may be eligible to participate in the ExoLuminate study if you*:
- Are 18 years of age or older
- Are able to provide a blood donation sample
AND if you have at least one of the following:
- Cystic lesions on the pancreas
- Newly-diagnosed diabetes type 2 after age 50
- Pancreatitis (acute, chronic or familial)
- Family history of pancreatic cancer
- Genetic predisposition for pancreatic cancer
*Pregnant females or those undergoing any active treatment from cancer diagnosis are not eligible to participate
Study participants will be compensated for donating samples. Results from testing will not be provided.
To get involved with and learn more about this study, visit ExoLuminate.com/join/pancreas-study or email exoluminate@biologicaldynamics.com. For detailed information about this study, visit ClinicalTrials.gov.
WebMAP CP
Researchers at Seattle Children’s Hospital want to learn more about pain management strategies to help youth with chronic pancreatitis. The study might be a good fit for you if you/your child is between 10 and 17 years old and has chronic or acute recurring pancreatitis. Families who participate will answer questions about pain, mood, sleep, and everyday life at 3 times over 9 months and use a website for 8-12 weeks, which might help with managing pain.
Families will receive $100 for each completed assessment ($300 in total). Results from this study may help other children who have chronic pain. To participate in this study or learn more, please contact the study team at 1-855-932-6272 or palermolab@seattlechildrens.org.
SHARP
MULTIPLE SITES
Researchers at the Medical University of South Carolina are researching whether a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum.
ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. Adults 18 years and older who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis within the last 24 months, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months. There are 16 sites for the trial. For more information, contact Dr. Gregory Cote at 503-494-5255 or coteg@ohsu.edu.
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of standardized stimulations to map the pain system.
QST has the potential to change and improve the treatment paradigm for patients with CP and may eventually be able to predict response to invasive CP therapies.
Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis (P-QST)
Abdominal pain in chronic pancreatitis (CP) affects up to 90% of patients during the course of their disease, and response to currently available therapies is suboptimal and unpredictable.
The proposed clinical trial will evaluate the predictive capability of Pancreatic Quantitative Sensory Testing (P-QST) – a novel assessment of neurosensory phenotyping- for improvement in pain in patients with CP who are undergoing medically-indicated invasive treatment with endoscopic therapy or surgery.