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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Pancreatitis

In brief

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

Key facts

Study ID

NCT02693093

Run by

Kangen Pharmaceuticals, Inc

People needed

264

Starts

2016-02-24

Expected to finish

2021-12-30

Last updated by the study team

2022-12-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible to participate in this study, subjects must meet all of the following criteria at Screening:
• Males and females aged 18 to 85 years, inclusive, at the time of consent
• Ability to communicate effectively with clinic site staff, ability and willingness to comply with the study schedule, restrictions, and requirements
• Institutional Review Board (IRB)-approved written informed consent
• Diagnosis of chronic pancreatitis
• Baseline average daily worst pain score must be a minimum of 4 using the Numeric Rating Scale (NRS) during the 7-day run-in period
• Patients on a non-opioid analgesic regimen that is expected to remain stable during the study period, or an opioid regimen with a morphine-equivalent dose not more than 100 mg daily.

You may not qualify if…

• To be eligible to participate in this study, subjects must not meet any of the following criteria:
• Any other clinically significant medical condition
• Treatment with any investigational product within 14 days of Day 1 (or 5 drug half-lives if 5 drug half-lives are expected to exceed 14 days) of Day -7
• Major abdominal surgery within 90 days of Day 1
• History or presence of clinically significant cardiovascular disease
• History of any cancer, except non-melanoma skin cancer, within 5 years of study enrollment,
• History of endoscopic intervention within the previous 3 months or presence of a pancreatic duct stent
• History of illicit drug abuse (i.e. use of any 'illegal' drugs within 6 months)
• Active heavy alcohol use (defined as more than 2 alcoholic drinks per day or 14 alcoholic drinks per week)
• Inadequate venous access
• Significant blood loss, donation of ≥450 mL of blood, or blood or blood product transfusion within 7 days of Day 1
• History or presence of hepatitis B (surface antigen positivity), active hepatitis C or human immunodeficiency virus (HIV) antibody
• Active infection within 30 days of Day 1
• Pregnant, planning to become pregnant or breast feeding
• Positive urine or serum pregnancy test result at Screening or on Day 1
• Active major psychiatric illness requiring a change in treatment within 3 months that would confound pain assessments
• History of seizures within the last 12 months
• Current use of anticonvulsants, antipsychotics, systemic steroids and, immunosuppressant therapy. *Use of gabapentin, pregabalin and benzodiazepines as treatment for chronic pancreatitis pain are allowed.
• Presence of generalized pain syndrome apart from chronic pancreatitis

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• Kaiser Permanente Medical Group — Los Angeles, California, United States
• University of Southern California, Keck School of Medicine — Los Angeles, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Colorado-Div of Gastroenterology and Hepatology — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• University of Florida - Division of Gastroenterology — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• The Carle Foundation Hospital — Urbana, Illinois, United States
• Indiana University - Indiana University Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Gastroenterology Associates of Western Michigan — Wyoming, Michigan, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Columbia University School of Medicine — New York, New York, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Ohio State University (OSU) - Wexner Medical Center — Columbus, Ohio, United States
• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Texas Clinical Research Institute — Arlington, Texas, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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