Welcome to the TACTIC clinical study website. TACTIC (The Assessment of Camostat Treatment in Chronic 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.
Find out if you could be an eligible participant in a clinical study evaluating the pain associated with Chronic Pancreatitis by answering our brief participant screener questionnaire
Participant Pre-Screener Questionnaire
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).
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.
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
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.
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
The TACTIC study has clinical sites located nationwide, at accredited major medical institutions.Please see our interactive map to find a site nearest you.
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.
Eligible study participants will be asked to complete six (6) visits over approximately 10 weeks.
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.
Key Eligibility Requirements for the TACTIC study:
Please take our participant pre-screener questionnaire to find out if you or someone you know may be eligible to participate.
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
Please visit the Participant Resource Page for additional study information.
Learn More About Participating HEREIf 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 StudyFor questions, or more information, contact the TACTIC clinical team
