A Dose Ranging Study Evaluating Efficacy and Safety of NI-03

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

Outcome

Missed primary endpoint

paper Changes in pain from baseline were similar between the camostat groups and placebo, with differences of least squares means of -0.11 (95% CI, -0.90 to 0.68) PMID 38103842 ↗

paper We were not able to reject the null hypothesis of no difference in improvements in pain or quality of life outcomes PMID 38103842 ↗

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	Unknown	100 mg	Oral
Subject	Camostat	Unknown	200 mg	Oral
Subject	Camostat	Unknown	300 mg	Oral

Indications