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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 Jul 23, 2026, 11:40 AM 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

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

  • NI-03 Drug
  • Placebo Drug

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 23, 2016
Primary completion
Sep 29, 2021
Completion
Dec 29, 2021
Last update posted
Dec 15, 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 15, 2022 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02693093 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →