KC Specialty Therapeutics, LLC is conducting a clinical trial to find out if a drug known as NI-03 is effective in relieving the symptoms of pain associated with chronic pancreatitis. The drug has been approved in Japan but has not been approved for sale in the United States. We are conducting this clinical trial to try and establish its effectiveness and then submit the results to the U.S. Food and Drug Administration (FDA).

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 clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Are clinical trials safe?

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

What can I expect at the clinical trial?

The clinical trial with Nl-03 will involve an initial visit to establish whether or not you will qualify for the study followed by 4 clinic visits over the next 5 weeks to ensure you are not experiencing any untoward effects during the trial, and to assess if the drug is working. If you are aged 18-85, have been diagnosed with chronic pancreatitis and are experiencing 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. You will take the medication three times a day with meals for 5 weeks. At each visit at least one blood sample will be taken, and on two
occasions you will be asked to remain at the clinic for up to 5 hours so that blood samples can be taken to measure the amount of drug that remains in your blood.

Where can I participate in a clinical trial?

The clinical trial is being performed in many centers around the country. If you are interested in participating in the clinical trial you should contact one of the centers listed below. The staff involved in the study will be able to tell you the requirements and answer any questions you might have. As a volunteer in a clinical trial you are free to withdraw any time you want without it having an impact on your future care.

For more information, please see our study details at: A Dose Ranging Study Evaluation Efficacy & Safety of NI-03