Clinical trials, also known as clinical studies, are research studies that explore if a new potential treatment will advance patient care; these studies are performed before the treatments are approved for use in the general population. Every new drug, medical device, biologic, vaccine, or treatment regimen must provide positive results of safety and effectiveness in a specific trial participant population before being approved for patient use. The trial participant population includes patients with the specific health concern that the drug is intended treat.These studies follow strict scientific standards to protect participants and ensure reliable results. If these results establish that the treatment being studied is safe and effective for the indication(s) being studied, the Food and Drug Administration (FDA) may approve the treatment for those specific patients in the United States.

New treatments must be studied in the laboratory first to determine safety, before they can be administered to people. Treatments which have acceptable safety profiles and show the most promise are then moved into clinical trials. For safety purposes, clinical trials start with a small group of volunteers or patients to find out whether a new drug causes any harm. In later phases of clinical trials, larger populations are involved, and researchers learn more about the benefits and possible risks of the new treatment when it is administered over longer periods of time. These studies follow a written plan called a protocol that specifies the procedures to be carried out and includes set instructions and standards to protect all participants. The protocol also ensures all information collected about the participants remains private and confidential. Before a clinical trial can begin, the protocol has to be approved by an independent group of doctors, nurses and lay people to make sure the protocol conforms to a globally set of ethics and procedures designed to ensure the participant’s safety.Clinical trials are designed to obtain consent at every step, so nothing will be done to a participant without their permission. In addition, protocols require that the health of participants are closely monitored and any safety concerns are promptly addressed. If the drug is found to cause harm or the participant cannot tolerate it for any reason, the trial team may discontinue treatment to that patient, and at any time, participants may leave the trial for any reason without it impacting their future medical care.

1. Clinical trials are a required step in bringing new breakthroughs in medicine from the researcher to the patient and these trials won’t happen without the participation of volunteers.
2. Participating in clinical trials may give access to cutting-edge treatments, and all participants will have access to a medical team that carefully monitors their disease and overall health.
3. For diseases that are caused by genetics, participation in clinical trials may help loved ones by advancing understanding of the disease and making new treatments available.
4. Participating in clinical trials helps others by contributing to research that could bring new treatments one step closer to reaching patients across the nation, not only for the disease being studied, but also for related conditions.
5. Clinical trials need participants of all backgrounds as some conditions are more prevalent within certain populations, whatever the age, race, gender or background.

Kangen Pharmaceuticals is conducting this clinical trial to find out if a drug known as NI-03 is effective in relieving the symptoms of pain associated with chronic pancreatitis (CP).The initial safety trial has already been completed and the current study is further evaluating the safety and effectiveness of NI-03 in relieving pain from CP. Any questions can be directed to the TACTIC team at info@tacticstudy.com or using the contact fields.

The clinical trial with NI-03 will involve an initial clinic visit by the potential participant to establish whether or not they qualify for this study.  If they qualify there will be 4 clinic visits over the next 5 weeks, once treatment begins, to ensure that they are not experiencing any unanticipated effects, and to assess if the drug is working. There will be one additional follow-up visit 4 weeks after completing treatment to ensure there have been no untoward effects after the treatment has been completed.During this trial, participants will be asked to keep a diary of their daily pain (on a 0 to 10 scale) and complete a short questionnaire during clinic visits to assess their responses to the treatment. Participants will take the medication three times a day at mealtime for 5 weeks. On two occasions they  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 their blood. The cost of the treatment and clinical tests are covered in clinical trials, and payment to subsidize travel and the participant’s time may be covered as well to lessen the burden of participation.Additional information is outlined in the TACTIC study section below.

To find out if you may qualify for the TACTIC trial, please visit the participant pre-screener questionnaire.This 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 TACTIC study site 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.