Pancreatitis Clinical Trials
- CP
- ADULTS > 18 YEARS
- MD, USA
- SINGLE SITE
- TREATMENT
Johns Hopkins Pancreatitis Pain Program
Johns Hopkins Pancreatitis Pain Program is a research and patient care program that brings pain relief and hope to patients with chronic pain caused by pancreatitis. In this program, a team of experts provide new pain treatments to help improve patients’ quality of life.
The Johns Hopkins team includes experts in different areas such as pain, digestion, and mental health, working together to reduce patient pain caused by pancreatitis. Their approach uses medications and therapies that work on nerves in your head and gut to treat your whole body. This program is one of the only places in the world to study the connection between mental health, pain, and pancreatitis.
Johns Hopkins Hospital (Meyer building), Baltimore, MD
Inclusion Criteria:
- Diagnosis of chronic pancreatitis for at least 12 weeks duration
- Completed blood tests and imaging
- Chronic abdominal pain that impacts your daily life
First Meeting: Information is gathered in tests and surveys. Doctors will give a treatment recommendation.
Follow-up Meetings: Every 3 to 4 months
End Date: Ongoing until patient opts out
Name: Coleman Brathwaite
Phone Number: 410-955-2343
- RAP
- ADULTS > 18 YEARS
- USA
- MULTI-SITE
- TREATMENT
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis (PirfenidoneRAP)
This trial will look into if Pirfenidone can prevent additional recurrent attacks of acute pancreatitis and the progression to chronic pancreatitis.
This clinical trial tests Pirfenidone, a drug approved for treating a disease called pulmonary fibrosis. Over six months, the trial will look at Pirfenidone in recurrent acute pancreatitis patients to see its ability to reduce inflammation and prevent the recurrence of pancreatitis episodes, aiming to improve the quality of life for participants.
University of Alabama Birmingham, Birmingham, Alabama | Brigham and Women’s Hospital, Boston, Massachusetts | Mayo Clinic, Rochester, New York
Open to adults aged 18-85 who have experienced two or more episodes of acute pancreatitis, with each episode separated by at least three months. Participants should not currently be experiencing acute pancreatitis or have been diagnosed with chronic pancreatitis.
Participants are required to visit the study site two and four weeks after the first visit and then once a month for the next 5-months of the treatment period. After two years, the patient will be requested to visit the study site again.
- CP
- ADULTS > 18 YEARS
- SC, USA
- SINGLE SITE
- TREATMENT
Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain (STEMCAP-1)
The investigators will test mesenchymal stem cells taken from the patient’s body as a treatment to reduce pain and inflammation due to chronic pancreatitis.
Mesenchymal stem cells have the proven potential to improve chronic pain in diseases. In this pilot study, participants will be given mesenchymal stem cells for chronic pancreatitis to measure changes in pain and quality of life as treatment is administered. This study may lead to mesenchymal stem cells as a standard of care if proven safe and effective.
Medical University of South Carolina, Charleston, SC
Inclusion Criteria:
- Age between 18 and 75 years old, male or female
- Definite chronic pancreatitis (stage 1-3)
- Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
- Baseline Izbicki pain score > 30
- Stable dose of opioids for the past 30 days
Exclusion Criteria:
- Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days. Diagnosis criteria requires that two or more of the following: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level greater than three times the upper normal value, or (c) characteristic imaging findings.
- Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
- Active cancer malignancies with the exception of non-melanoma skin cancer.
- Patients with planned endoscopic or surgical procedures in the next 6 months.
- Pregnant women.
There will be four visits to the clinic over a 6-month period. Once in the beginning, at 1 month into the trial, at 3 months into the trial, and again at the end of the study after 6 months pass.
Name: Hongjun Wang, Ph.D.
Phone Number: 843-792-1800
Email: wangho@musc.edu
Name: Charlton Strange III, MD
Phone Number: 843-792-3174
Email: strangec@musc.edu
- CP
- ADULTS > 18 YEARS
- DENMARK
- SINGLE SITE
- TREATMENT
Tocilizumab for Painful Chronic Pancreatitis (TOPAC)
This study will look into if tocilizumab can help reduce pain due to pancreatitis and make life better for patients with chronic pancreatitis.
Tocilizumab is an antibody that interacts with a common inflammation causing molecule, and is currently used to treat diseases such as arthritis. The researchers believe that Tocilizumab can potentially reduce chronic pancreatitis pain, decrease pancreatic inflammation, and improve day-to-day life in patients with chronic pancreatitis.Â
Aalborg University Hospital, Aalborg, Nordjylland, Denmark
Inclusion Criteria:
- Chronic pancreatitis patients
- Stomach pain
- Evidence of ongoing pancreatic inflammatory activity, hence one or more pancreatitis attacks within the past six months.
- 18 years of age or older
Exclusion Criteria:
- Do not drink alcohol or use drugs for six months before joining the study
- Positive test for Tuberculosis
- Positive test for Hepatitis
- Severe liver disease
- Pregnancy
- No contraception use
There will be six visits over 24 weeks. You will see the doctor every four weeks.
Name:Â Rasmus Hagn-Meincke, MD
Phone Number:Â 004597663520
Email:Â r.hagnmeincke@rn.dk
- CP/RAP
- ADULTS > 18 YEARS
- USA & CANADA
- REMOTE
- TREATMENT
Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain (IMPACT-2)
This study will look at how an online pain self-management program can potentially minimize the impact of pancreatitis pain and improve quality of life. The ultimate goal is to make sure the intervention has a big impact on public health by successfully getting it to pancreas clinics and the community.
This new treatment program focuses on pain management without using drugs. The researchers of this clinical trial aim to collect data on how effective internet-delivered pain self-management is for people with recurrent acute and chronic pancreatitis. The study team will teach pain self-management skills such as relaxation, activity pacing, and goal setting. The outcomes of this study will provide new solutions for non-opioid pain management in chronic pancreatitis. Participants will receive monetary compensation for completing all of the study activities.
Virtual – US or Canada
Inclusion Criteria:
- Age 18 years and older
- Have a willingness to use personal devices with internet access (smart phone, computer, iPad) or to borrow a study iPad/hotspot.
- Diagnosis of chronic pancreatitis with clear identifiable physical signs of the condition OR diagnosis of recurrent acute pancreatitis (having abdominal pain of a duration of more than 3 months, one episode of acute pancreatitis acute pancreatitis, or recurrent acute pancreatitis.
- Having experienced moderate pain intensity in the last month from recurrent acute or chronic pancreatitis
Exclusion Criteria:
- Undergoing treatment for cancer
- Unable to read English well enough to complete questionnaires or read the study website
- Currently experiencing suicidal thoughts
Participants will log in to the website for 15-20 minutes per week and complete five tasks focused on different skills delivered over eight weeks. Questionnaires about the training experience and their pain will be administered once in the beginning, again after two months, and finally six months after the program begins.
There is no in-person requirement for this clinical trial.
Name: Olivia Ohls
Email: olivia.ohls@seattlechildrens.org
Phone Number: (206) 884-1559
Name: Tonya Palermo, PhD
Email:Â tonya.palermo@seattlechildrens.org
Phone Number:Â (206)-884-4208
- RAP & CP
- ADULTS > 18 YEARS
- USA
- SINGLE-SITE
- TREATMENT
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis (SMV in CP)
The study team believes that treatment with simvastatin will have a significant benefit for reducing pain, improving quality of life and other pancreatitis-related outcomes in patients with chronic pancreatitis and recurrent acute pancreatitis.
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Los Angeles, CA
Inclusion Criteria:
- 18-75 years old
- Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis.
- No prior pancreatic surgery
- No current statin use for 6 months.
Exclusion Criteria:
- Pregnancy or lactation
- History of autoimmune, medication caused or traumatic pancreatitis.
- Pancreatic tumors
- Pancreatic metastasis from other malignancies.
- History of solid organ transplant, HIV/AIDS.
- Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).
- Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.
- Patients with active liver disease.
Participants will visit the clinic four times throughout the trial. The visits will occur at the beginning of the trial, three months after the first visit, six months after the first visit, and the final visit will occur after twelve months have passed from beginning the trial.
Name: Marissa Podell
Email: marissa.podell@cshs.org
Phone Number: 310-967-1109
Principal Investigator: Stephen Pandol, MD
- CP
- ADULTS > 18 YEARS
- CA, USA
- SINGLE SITE
- TREATMENT
A Pilot Clinical Trial of Paricalcitol for Chronic Pancreatitis (ALLIANCE)
The proposed trial will examine the feasibility of testing the effect of the vitamin D analog, paricalcitol (also known as Zemplar), on health-related quality of life, imaging, and biomarkers in patients with chronic pancreatitis (CP).
This study is the initial stage of investigating whether Paricalcitol could benefit individuals with chronic pain, while also exploring specific markers to determine its effectiveness. It is our hope that paricalcitol treatment will improve symptoms and reduce the pain of chronic pancreatitis where there is currently no non-surgical option.
Cedars-Sinai Medical Center, Los Angeles, CA
Inclusion Criteria:
- Male or female, aged 18-75 at time of enrollment
- Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e. suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis.
- Ability to take oral medication and be willing to adhere to the dosing regimen
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 week after the end of Investigational Product administration
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- No prior pancreatic surgery
- No involvement in any interventional trials currently or within 6 months of enrollment
Exclusion Criteria:
- Pregnancy or lactation
- Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria)
- Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator’s opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up
- Currently incarcerated
- Inability to tolerate MRI
There will be three visits to the clinic over a 12-month period. Once in the beginning, at 6 months, and again at the end of the study after 12 months pass.
Name: Marissa Podell
Phone Number: 310-967-1109
Email: marissa.podell@cshs.org
Principal Investigator: Stephen Pandol, MD
- CP
- ADULTS > 18 YEARS
- USA
- MULTI-SITE
- TREATMENT
Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis (STTEPP)
The researchers plan to study lacosamide, an FDA-approved anti-epilepsy medication, in combination with opioid therapy in patients suffering from chronic abdominal pain due to chronic pancreatitis (CP).
The researchers believe that combining lacosamide with opioids will enhance the effectiveness of opioids in managing pain in patients with chronic pancreatitis (CP). This study will look into what the best dosage of lacosamide and opioid is to best manage pain in CP patients.
Stanford, California | Indianapolis, Indiana | Rochester, Minnesota | Columbus, Ohio | Pittsburgh, Pennsylvania
Inclusion Criteria:
- ≥ 18 years old at the time of informed consent;
- Suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain
- Patients must be maintained on an opioid (except methadone or suboxone) for 4 weeks prior to enrollment for treatment of abdominal pain related to pancreatitis, with a daily morphine equivalent dose of 20-120mg
- Ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment)
Exclusion Criteria:
- Treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent
- Rapidly escalating pain that requires hospitalization or intravenous opioid therapy
- Known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine
- Pregnant or breastfeeding
- Patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs
- Abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment
- Hospitalization for pancreatitis exacerbation or pain management within 90 days of enrollment
Study Visit 1: Baseline study assessments and questionnaires in-person and then 7 days of treatment
Study Visit 2: After 7-day treatment period, there will be a clinic visit on day 8. Similar assessments and questionnaires will be used.
Follow-up: phone visit will occur on day 21 to assess for adverse events and medication changes
Name: Evan L Fogel, MD
Phone Number: 317-944-2816
Email: efogel@iu.edu
Secondary Contact:
Name: Fletcher A White
Phone Number: 317-274-5164
Email: fawhite@iu.edu
- RAP & CP
- PATIENTS > 16 YEARS
- MN, USA
- SINGLE SITE
- PROCEDURE
Long-Term Islet Function and Impact after Total Pancreatectomy with Islet Autotransplant (LIFT)
The University of Minnesota is looking for people aged 16 and older who had their pancreas completely removed, with or without an islet transplant, between 5 and 20 years ago. They aim to increase their understanding of diabetes after pancreas surgery.
This study aims to find out the long-term effectiveness of islet grafts (transplants) and their impact on diabetes complications after total pancreatectomy and autologous islet transplantation (TPIAT). Researchers want to improve the understanding of the body’s long-term blood sugar control. They will measure islet graft function by checking C-peptide levels during mixed meal tolerance tests. Individuals who had a total pancreatectomy with and without islet transplantation at any hospital are encouraged to participate; however, those without islet transplantation are especially needed. Participants will be required to visit the University of Minnesota for 2-3 days of testing. The clinical trial will cover travel costs and pay participants.
University of Minnesota Twin Cities, Minneapolis, MN
Inclusion Criteria:
- 16 years or older who have had a total pancreatectomy with or without an islet transplant 5 to 20 years ago
- People who had a total pancreatectomy without islets at any center are particularly needed.
This study will include a single ‘visit’ spanning 2-3 days to complete multiple tests.
Program Officer:
Name: Peggy Ptacek
Phone Number: 612-626-5905
Email: vorwa001@umn.edu
- RAP & CP
- ADULTS > 18 YEARS
- MULTI-COUNTRY
- MULTI-SITE
- PROCEDURE
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
In this study, researchers will use Quantitative Sensory Testing (QST) to learn more about the patterns of pain in patients with Chronic Pancreatitis (CP), with the goal to predict therapy responses and improve treatment results.
QST is a new way of studying chronic pain in various diseases. Researchers will use it in this study to understand the pain patterns in patients with CP. QST uses a set of standardized tests to map out how the pain system works. QST could completely change how we treat CP patients and help predict treatment responses.
Aalborg, Denmark | Halle, Germany | Alicante, Spain | Budapest, Hungary | Hyderabad, India | New Dehli, India | Auckland, New Zealand | Boston, Massachusetts | Baltimore, Maryland | New York, New York | Cincinnati, Ohio | Columbus, Ohio | Pittsburgh, Pennsylvania | Dallas, Texas | Indianapolis, IndianaÂ
Inclusion Criteria:
- 18 years or older in age
- Suspected CPs Inclusion Criteria
- Pantients with a) Indeterminate CP (Cambridge 1 or 2 on CT scan or MRI/MRCP) who have abdominal pain without prior history of AP, or b) those with acute (AP) or recurrent acute pancreatitis (RAP) who have recovered from their attack(s) of AP, whose imaging studies are either normal or show changes consistent with Cambridge classification of 1 or 2, and they have ongoing abdominal pain. Both diabetic and non-diabetic patients will be allowed to enter the study.
- Patients must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).
- Definite Chronic Pancreatitis – Inclusion Criteria
- Patients will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4). Both diabetic and non-diabetic subjects will be allowed to enter the study.
Exclusion Criteria:
- Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Patients suffering from painful conditions other than pancreatitis or Sphincter of Oddi Dysfunction (SOD) type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Patients with known pregnancy at the time of enrollment.
- Patients who have previously undergone surgical intervention on their pancreas.
First Visit: QST Testing and questionnaire
Follow-up Visits: Patients undergoing endoscopic or surgical therapy will have follow-up testing consisting of the same tests at 1, 3, and 6 months post-procedure
Name: Anna Evans Phillips, MD
Phone Number: 412-647-2345
Email: evansac3@upmc.edu
- CP
- ADULTS > 18 YEARS
- USA
- MULTI-SITE
- PROCEDURE
Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Pancreatic Quantitative Sensory Testing (P-QST) is a new method of measuring pain sensitivity. In this clinical trial, they will test how well P-QST can predict pain improvement in patients with chronic pancreatitis (CP) after they receive endoscopic therapy or surgery.
Researchers will use the results from P-QST to create a tool to predict how a patient will respond to treatment. P-QST will be used to identify baseline pain before endoscopic therapy or decompressive surgery. The results will be used to test and create a model to estimate individual responses to treatment.
Indianapolis, Indiana | Baltimore, Maryland | Pittsburgh, Pennsylvania
Inclusion Criteria:
- Adult patients ≥ 18 years of age with definite CP undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain.
- Endoscopic therapy: Endoscopic Retrograde Cholangiopancreatography (ERCP) with pancreatic duct stone removal, stent placement, and/or stricture dilation, ± intraductal lithotripsy or Extracorporeal Shock Wave Lithotripsy (ESWL).
- Surgery: drainage procedures (Frey and Puestow operations)
Exclusion Criteria:
- Patients with chronic pain from conditions other than CP
- Patients who have had endoscopic therapy within the past 12 months
- Patients who have undergone prior pancreatic surgery
- Patients who have resective surgical procedure planned (eg. Whipple procedure, Total Pancreatectomy)
- Patients with peripheral sensory deficits
- Patients with known pregnancy at the time of study screening**
- Note: Women who become pregnant during the course of the study can no longer participate in P-QST testing.
First Visit: pre-procedure P-QST testing before scheduled treatment as directed by their treating gastroenterologist.Â
Follow-up Visits: Scheduled at 3, 6, and 12 months after the first endotherapy session or surgery.
Name: Anna Evans Phillips, MD
Phone Number: 412-647-2345
Email: evansac3@upmc.edu
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