1. 01WELCOME

    Welcome to the TACTIC clinical study website. TACTIC (The Assessment of Camostat Treatment iChronic Pancreatitis) is a study currently investigating a novel compound for the treatment of pain associated with Chronic Pancreatitis, for which there is currently no treatment in the US. If you, or someone you know may be interested to learn more about this study, this site will provide eligibility requirements and help you locate a study clinic nearest you.

ABOUT CLINICAL TRIALS

  1. Chronic Pancreatitis

    Kangen Pharmaceuticals is conducting a clinical study to find out if a drug known as NI-03 is effective in relieving the symptoms of pain associated with Chronic Pancreatitis. The drug is approved in Japan but has not been approved for sale in the United States. We are conducting this clinical study to  establish its safety and effectiveness and plan to submit the results to the U.S. Food and Drug Administration (FDA).

  2. What are Clinical Trials?

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

  3. Are Clinical Trials Safe?

    For safety purposes, clinical studies start with small groups of participants to find out whether a new drug causes any harm. In later phases of clinical studies, larger populations are involved, and researchers learn more about the risks and benefits of the new drug. The clinical study follows a written plan called a protocol, which specifies the procedures to be carried out, and ensures all information collected about you remains confidential

  4. What Can I Expect at the Clinical Trial?

    The clinical study with NI-03 will involve an initial clinic visit to establish whether or not you will qualify, followed by 4 clinic visits over the next 5 weeks to ensure you are not experiencing any unanticipated effects, and to assess if the drug is working. There will be a Follow-Up visit 4 weeks after completing treatment to assess safety.

    If you are aged 18-85 years, have been diagnosed by a doctor with Chronic Pancreatitis by testing such as CT or MRI or Endoscopic Ultrasound, and are experiencing daily pain associated with this disease for which you may be taking medications for pain relief, you may be eligible to participate.

    During the study you will be asked to keep a record of your daily pain and complete questionnaires when you visit the clinic to assess your response to the treatment. You will take the medication three times a day at mealtime for 5 weeks. On two occasions you will be asked to remain at the clinic for up to 6 hours, so that blood samples can be taken to measure the amount of drug that remains in your blood. The study will provide compensation for travel and time off work.

  5. Where & How can I participate in a Clinical Trial?

    To find out of you may qualify for this chronic pancreatitis clinical trial, please visit the Participant Pre-Screener Questionnaire.

    The study is being performed in many medical centers around the country. If you are interested in participating and have completed the participant screener questionnaire, you may also contact one of your local participating centers listed on the Clinical Location Map. The staff involved in the study will be able to review your eligibility and answer any questions you might have. As a volunteer in a clinical study you are free to withdraw at any time without it having an impact on your future care.

    You may also learn more about each of the participating clinical study sites and physicians at Clinicaltrials.gov, here: https://clinicaltrials.gov/ct2/show/study/NCT02693093?show_locs=Y#locn

Our Mission

  • To develop a potential new drug for patients with Chronic Pancreatitis who have limited options for treatment and which may include the use of opiates and other medications which offer little benefit to the underlying disease
  • To connect patients who have Chronic Pancreatitis to a clinical research study performed by doctors who are leaders in the field of pancreatitis
  • To provide quality healthcare in a research center evaluating possible new treatments for Chronic Pancreatitis

key details about our servicesTHE TACTIC STUDY

Study Overview

The TACTIC clinical study is investigating a new drug, NI-03, for the treatment of the acute pain associated with Chronic Pancreatitis.  Currently there is no approved medication in the United States for this disease. The TACTIC study is currently enrolling eligible participants in the US. There are clinical study sites at multiple locations, nationwide.

 

Clinical Monitoring

During the study you will have blood tests at four (4) visits. At two (2) of these visits you will be asked to remain at the clinic for approximately 6 hours. Participants will also have other study procedures, such as physical exams and electrocardiograms (electrical tracing of your heart) taken during the visits. Participants will be asked about any adverse effects you may experience and changes in your current medications.

Participants will be asked to record their daily pain levels in a diary each night before bedtime evaluating your pain over the previous 24-hours. The data gathered from the study at both the clinic and from the pain diary information will help determine if the effectiveness of the investigational drug for treating pain associated with Chronic Pancreatitis.

Study Length

Eligible study participants will be asked to complete six (6) visits over approximately 10 weeks.

Study Dosing

Study medication given to participants will be either the investigational drug or a placebo and are assigned randomly (like flipping a coin). You will not be told which drug you are assigned and neither will your doctor or the study team (except in an emergency). The study drugs are provided by the study site and should be taken by the participant at home, three times per day. On two visits, you will take the study medication at the clinic.

Who Can Participate?

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 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

Please take our participant pre-screener questionnaire to find out if you or someone you know may be eligible to participate.

Where Can I Find a Site Near Me?

The TACTIC study has clinical sites located throughout the United States. To find a local site nearest you, please visit the TACTIC Study Site Location Map, where you can search by zip code:

TACTIC Study Site Location Map

  1. 02PHYSICIAN RESOURCES

    If you are interested in participating as a site/Study Investigator, or have a potential patient who may be eligible as a participant in the TACTIC study, please see the Physician Resource page for  additional information.

    Learn More About TACTIC Study

keep in touchCONTACT US

Contact Info

For questions, or more information, contact the TACTIC clinical team

Contact Us
  • 4 + 59 =
Find a Local Clinic Near You