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A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis

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A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 19 Dec 2023

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At a glance

  • Drugs Camostat mesilate (Primary)
  • Indications Pancreatitis
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms TACTIC
  • Sponsors Kangen Pharmaceuticals; Stason Pharmaceuticals

    • Most Recent Events

    • 14 Dec 2023 Primary endpoint has not been met, (Phase 2 - Efficacy Analysis - average daily worst pain intensity score), as per Results published in the Gastroenterology
    • 14 Dec 2023 Results published in the Gastroenterology
    • 26 Sep 2022 Status changed from active, no longer recruiting to completed.

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