Last updated on November 2019

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

Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT02693093

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Val R. Hansen, MD

Bountiful, UT United States
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