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

Chronic Pancreatitis Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of NI-03.

Clinical Trial Description

The primary objective of the Single-Dose Phase is to assess the pharmacokinetics (PK) and safety of single doses of NI-03 when administered at doses of 100 mg, 200 mg or 300 mg to subjects with chronic pancreatitis. The primary objective of the Double-Blind Phase of the 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) for 28 consecutive days in subjects with chronic pancreatitis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02693093
Study type Interventional
Source Kangen Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 24, 2016
Completion date December 30, 2021
View Details
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