The TACTIC clinical study is investigating a drug compound, NI-03, a serine protease inhibitor that may potentially act in several ways to prevent or block the development of pancreatitis. NI-03 has been approved in Japan since 1985 for the treatment of acute pain associated with Chronic Pancreatitis, and there are no approved medications in the United States for the relief of pain associated with Chronic Pancreatitis. This study is designed to support regulatory approval of NI-03 in the US.
The TACTIC study is currently enrolling subjects for a phase 2, randomized, double- blind, parallel-group, dose-ranging study to evaluate the efficacy and safety of NI-03 compared to placebo in subjects with Chronic Pancreatitis, including PK assessments. All subjects will complete a five-week treatment period to one of four blinded treatments (placebo, 100 mg, 200 mg or 300 mg) self-administered TID.
Screening Period: A 7-day Run-In period will be conducted to establish subject baseline assessments of pain and to familiarize participants with the 11-point numeric rating scale (NRS). Safety lab assessments along with ECG, PE and other study related procedures will be performed to assess the study baseline.
Dosing Period: After Screening, subjects will be randomized to 1 of 4 treatment groups according to their level of the daily opiate use. Study drug will be self-administered three-times daily with food. At each visit, dosing compliance will be reviewed, safety assessments will be performed, and blood samples will be collected.
There will be two visits which require serial PK collection (6 time points over 6 hours). Subjects will be asked to remain at the clinic until all PK collection is completed.
Follow-Up Period: Subjects will have an End of Study (EOS) Visit for safety assessments. For subjects who discontinue early from the study, these assessments should be completed within 7 days of the subject receiving their last dose of study medication.
Primary & Secondary Objectives
The primary objective of the TACTIC study is to determine the efficacy, PK, and safety of three doses of NI-03 (100 mg, 200 mg, and 300 mg) as compared to placebo when administered three times daily (TID) in subjects with Chronic Pancreatitis.
Secondary objectives are to evaluate the safety of NI-03 compared to placebo in subjects with Chronic Pancreatitis and to compare the PK profiles of the three doses of NI-03 in this population. Using the PANQOLI and Brief Pain Inventory, the study will also examine the impact of NI-03 on the quality of life (QOL) of subjects with Chronic Pancreatitis.
During the TACTIC study, patients will have an initial clinic visit to establish eligibility, followed by 4 clinic visits over the next 5 weeks to ensure there are no unanticipated effects during the trial, and to assess efficacy. At each clinic visit at least one blood sample will be taken, and on two occasions patients will be asked to remain at the clinic for up to 5 hours to measure concentration of remains drug in the patient’s blood. Before receiving any study drug during the Double-Blind Phase and at pre-specified post-dose time points, vital signs will be measured, adverse events (AEs) and concomitant medication use will be queried, an ECG will be performed, blood and urine samples will be collected for clinical laboratory tests, urine pregnancy test (for female subjects of child-bearing potential) will be performed, blood samples will be collected for determination of PK parameters, and the BPI and PANQOLI will be completed. Subjects will return to the study clinic on Days 15, and 29 for completion of study assessments.
Key Eligibility Criteria
- Males or females aged 18-85 years of age
- Clinical diagnosis of Chronic Pancreatitis through EUS, CT, MRI, MRCP, ERCP which confirms the Rosemont and/or Cambridge criteria
- Experiencing an average, daily worst pain score of at least 4 on an 11-point scale (0 = No pain and 10= worst pain imaginable)
- On a non-opioid analgesic regimen that is expected to remain stable during the study period, or an opioid regimen with an oral morphine-equivalent dose of ≤ 100 mg daily
- Not pregnant, planning to become pregnant or breast feeding, and not have a positive serum or urine pregnancy test result during the study
- No current history of active heavy alcohol use (defined as more than 2 alcoholic drinks per day or 14 alcoholic drinks per week)
(Please contact our TACTIC clinical team for a comprehensive list of participant inclusion & exclusion requirements @ email@example.com. You may also access the participant pre-screener to find out if your patient might be eligible)
Study Site Locations
TACTIC currently has clinical study sites enrolling participants, nationwide. If you may have eligible patients diagnosed with Chronic Pancreatitis or are interested in learning more about participating as a study site, please contact the TACTIC study team at firstname.lastname@example.org.
To learn more about the participating clinical sites & physicians, please see more details at at Clinicaltrials.gov, here. <link, https://clinicaltrials.gov/ct2/show/study/NCT02693093?show_locs=Y#locn