drugset / Trial / NCT02693093
A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine the safety and efficacy of NI-03.
Timeline
- Start
- 2016-02-24
- Primary completion
- 2021-09-30
- Completion
- 2021-12-30
Publications
- Hart PA, Osypchuk Y, Hovbakh I, Shah RJ, Nieto J, Cote GA, Avgaitis S, Kremzer O, Buxbaum J, Inamdar S, Fass R, Phillips RW, Yadav D, Ladd AM, Al-Assi MT, Gardner T, Conwell DL, Irani S, Sheikh A, Nuttall J; TACTIC Study Investigators. A Randomized Controlled Phase 2 Dose-Finding Trial to Evaluate the Efficacy and Safety of Camostat in the Treatment of Painful Chronic Pancreatitis: The TACTIC Study. Gastroenterology. 2024 Apr;166(4):658-666.e6. doi: 10.1053/j.gastro.2023.12.008. Epub 2023 Dec 15.
- Ramsey ML, Nuttall J, Hart PA; TACTIC Investigative Team. A phase 1/2 trial to evaluate the pharmacokinetics, safety, and efficacy of NI-03 in patients with chronic pancreatitis: study protocol for a randomized controlled trial on the assessment of camostat treatment in chronic pancreatitis (TACTIC). Trials. 2019 Aug 14;20(1):501. doi: 10.1186/s13063-019-3606-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camostat | Small molecule | 100 mg | Oral |
| Subject | Camostat | Small molecule | 200 mg | Oral |
| Subject | Camostat | Small molecule | 300 mg | Oral |