Participant Resources

Chronic Pancreatitis

What is Chronic Pancreatitis & what are the symptoms?

The pancreas is an organ located behind your stomach dedicated to producing enzymes (special proteins) that help digest your food. The pancreas is also responsible for making hormones that control sugar levels in your bloodstream. 

Chronic pancreatitis (CP) is a long-term inflammation of your pancreas that does not improve over time and which causes abdominal pain. Common symptoms include stomach pain, back pain, nausea, vomiting, fat and nutrient malabsorption, and oily bowel movements. Pain can come and go, or be constant and severe. Chronic pancreatitis often develops in patients between the ages of 30 and 40, and is more common in men than women.

 Inflammation of the pancreas due to CP may result in the development of calcium stones and cysts, which can block the duct that carries digestive enzymes to your stomach. This type of blockage may decrease your levels of pancreatic enzymes and hormones, making it more difficult for you to digest food and regulate blood sugar. Overall, this can sometimes cause serious health problems, including malnutrition, diabetes, and a possible increased risk for pancreatic cancer.

For more resources about chronic pancreatitis, pease visit the National Pancreas Foundation.

Why Did I get chronic pancreatitis?

CP is a complex condition and the causes are not completely understood. The most common causes are long-term alcohol abuse and smoking, but there are numerous other causes of chronic pancreatitis. These include:

  • autoimmune disease, which occurs when your body mistakenly attacks your healthy cells and tissues
  • inflammatory bowel syndrome, which is inflammation of the digestive tract
  • primary biliary cholangitis, which is a chronic liver disease
  • narrowing of the pancreatic duct, which is the tube that carries enzymes from the pancreas to the small intestine
  • a blockage of the pancreatic duct by either gallstones or pancreatic stones
  • cystic fibrosis
  • genetics
  • high blood levels of calcium known as hypercalcemia
  • high level of triglyceride fats in your blood known as hypertriglyceridemia  

What current treatments are available?

Currently, there are no approved medications for the treatment of CP in the United States. There are multiple recommendations to managing the symptom of pain including lifestyle changes (adopting a low-fat diet and abstaining from tobacco and alcohol). There are also recommendations for pain management beginning with over the counter painkillers eventually leading to prescription opioids.  Treatment failure or only partial success is common with the current medication options. Non-medication options include nerve blocks, endoscopic therapy, and various surgical procedures.

Why is there a need for a new treatment?

Current treatments only address the symptom of chronic pain, often not effectively, and none directly address the cause of the disease. Patients report that managing pain is the most common and difficult aspect of CP. It is common to use opioids to manage the pain associated with CP. There are significant dangers with continued opioid use, including addiction, and overdose; thus it is crucial to find other treatments that are more effective at managing pain without the associated risks of dependency.

With inadequate treatment, there is a heavy financial burden to the patient and their family, including the cost of doctor’s visit, hospital admissions, pain management, surgical procedures and complications. Other burdens include missed work/school days, early retirement, and decreased quality of life.

CHRONIC PANCTREATITIS PATIENT EXPERIENCE

Patient perspective

Patients often find that having CP can be isolating and difficult to manage. During new-drug development, it is important that patients’ opinions and experiences be heard. The National Pancreas Foundation (NPF) has launched a pancreatitis support community in partnership with INSPIRE, a health social network site, where patients, caregivers, and physicians can have open discussions. This community site can be accessed here. 

Mission:Cure is a non-profit organization founded in 2017 to discover life-altering therapies and bring them to patients. Pancreatitis is the first disease they’ve decided to study. In 2018, Mission:Cure launched a patient survey to help patients share their stories. The results of that survey can be found here.

Clinical Trials – Do I qualify for the TACTIC Study?

Clinical trials are research studies that explore whether a medical strategy or treatment is safe and effective for humans. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

The TACTIC study is investigating the effectiveness of an oral drug (NI-03) for treatment of pain caused by Chronic Pancreatitis. Currently, the TACTIC study is enrolling study participants at multiple study clinics nationwide. To be considered as an eligible study participant, participants must satisfy the following study criteria: 

Key Eligibility Requirements for the TACTIC study:

  • Must be between 18-85 years of age
  • Have a clinical diagnosis of Chronic Pancreatitis
  • Have not experienced seizures in the last 12 months
  • Have not been diagnosed with any form of cancer within the last 5 years (excluding non-melanoma skin cancer)
  • Do not have active active Hepatitis B, Hepatitis C, or HIV
  • Do not consume more than 2 alcoholic drinks per day (14 drinks/ week)
  • Are willing to use accepted forms of birth control or contraception through course of the study and are not pregnant, or planning to become pregnant

To see if you, or someone you know might qualify, please see our participant pre-screener questionnaire to answer preliminary questions about your eligibility to participate and leave a message for our study team members.

Please Note: A comprehensive list of study eligibility requirements will be further discussed with the clinical team prior to study enrollment.

Clinic Location Map

Please reference the TACTIC Clinic Location Map to find a clinic closest to you. You may contact the study clinic directly for more information, or to learn more about eligibility for the TACTIC study for Chronic Pancreatitis at info@tacticstudy.com.

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