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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT02693093

Public ClinicalTrials.gov record NCT02693093. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 30, 2026, 3:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02693093
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Kangen Pharmaceuticals, Inc
Industry
Enrollment
264 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 24, 2016 (Actual)
Primary completion
Sep 30, 2021 (Actual)
Completion
Dec 30, 2021 (Actual)
Last update posted
Dec 16, 2022

2016 – 2021

United States locations

U.S. sites
28
U.S. states
20
U.S. cities
27
Facility City State ZIP Site status
University of Arkansas Little Rock Arkansas 72204 —
Kaiser Permanente Medical Group Los Angeles California 90027 —
University of Southern California, Keck School of Medicine Los Angeles California 90033 —
Stanford University School of Medicine Stanford California 94305 —
University of Colorado-Div of Gastroenterology and Hepatology Aurora Colorado 80045 —
Yale School of Medicine New Haven Connecticut 06519 —
University of Florida - Division of Gastroenterology Gainesville Florida 32608 —
Borland-Groover Clinic Jacksonville Florida 32256 —
Gastroenterology Group of Naples Naples Florida 34102 —
The Carle Foundation Hospital Urbana Illinois 61801 —
Indiana University - Indiana University Hospital Indianapolis Indiana 46202-5149 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
UMass Memorial Medical Center Worcester Massachusetts 01605 —
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047 —
Gastroenterology Associates of Western Michigan Wyoming Michigan 49519 —
Kansas City Research Institute Kansas City Missouri 64131 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
Columbia University School of Medicine New York New York 10027 —
PMG Research of Winston-Salem Winston-Salem North Carolina 27103 —
MetroHealth Medical Center Cleveland Ohio 44109 —
Ohio State University (OSU) - Wexner Medical Center Columbus Ohio 43210 —
UPMC Presbyterian Pittsburgh Pennsylvania 15213-2536 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Texas Clinical Research Institute Arlington Texas 76012 —
Texas Tech University Health Sciences Center El Paso Texas 79905 —
Baylor College of Medicine Houston Texas 77030 —
Virginia Mason Seattle Washington 98101 —
Wisconsin Center for Advanced Research, a division of GI Associates LLC Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02693093, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 16, 2022 · Synced Sep 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02693093 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →