A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
NCT ID: NCT02693093
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
264 participants
INTERVENTIONAL
2016-02-24
2021-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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placebo
TID Day for 28 Days
Placebo
100 mg NI-03
TID Day for 28 Days
NI-03
200 mg NI-03
TID Day for 28 Days
NI-03
300 mg NI-03
TID Day for 28 Days
NI-03
Interventions
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NI-03
Placebo
Eligibility Criteria
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Inclusion Criteria
1. Males and females aged 18 to 85 years, inclusive, at the time of consent
2. Ability to communicate effectively with clinic site staff, ability and willingness to comply with the study schedule, restrictions, and requirements
3. Institutional Review Board (IRB)-approved written informed consent
4. Diagnosis of chronic pancreatitis
5. 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
6. 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.
Exclusion Criteria
1. Any other clinically significant medical condition
2. 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
3. Major abdominal surgery within 90 days of Day 1
4. History or presence of clinically significant cardiovascular disease
5. History of any cancer, except non-melanoma skin cancer, within 5 years of study enrollment,
6. History of endoscopic intervention within the previous 3 months or presence of a pancreatic duct stent
7. History of illicit drug abuse (i.e. use of any 'illegal' drugs within 6 months)
8. Active heavy alcohol use (defined as more than 2 alcoholic drinks per day or 14 alcoholic drinks per week)
9. Inadequate venous access
10. Significant blood loss, donation of ≥450 mL of blood, or blood or blood product transfusion within 7 days of Day 1
11. History or presence of hepatitis B (surface antigen positivity), active hepatitis C or human immunodeficiency virus (HIV) antibody
12. Active infection within 30 days of Day 1
13. Pregnant, planning to become pregnant or breast feeding
14. Positive urine or serum pregnancy test result at Screening or on Day 1
15. Active major psychiatric illness requiring a change in treatment within 3 months that would confound pain assessments
16. History of seizures within the last 12 months
17. Current use of anticonvulsants, antipsychotics, systemic steroids and, immunosuppressant therapy. \*Use of gabapentin, pregabalin and benzodiazepines as treatment for chronic pancreatitis pain are allowed.
18. Presence of generalized pain syndrome apart from chronic pancreatitis
18 Years
85 Years
ALL
No
Sponsors
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Kangen Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Phiip Hart, MD
Role: PRINCIPAL_INVESTIGATOR
OSU
Locations
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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
Baylor College of Medicine
Houston, Texas, United States
Virginia Mason
Seattle, Washington, United States
Wisconsin Center for Advanced Research, a division of GI Associates LLC
Milwaukee, Wisconsin, United States
Federal Research Centre Institute of Cytology and Genetics
Novosibirsk, , Russia
Military Medical Academu, Dep of Therapy of Adv. Training
Saint Petersburg, , Russia
Military Medical Academy, Department of Hospital Therapy
Saint Petersburg, , Russia
1st Saint Petersburg State Medical University
Saint Petersburg, , Russia
City Hospital #40
Saint Petersburg, , Russia
City Polyclinic #4
Saint Petersburg, , Russia
Medical University "Reaviz"
Samara, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Institute of Gastroenterology
Dnipro, , Ukraine
Central city Clinical Hospital, Therapeutic Department #2
Ivano-Frankivsk, , Ukraine
Malaya Therapy National Institute
Kharkiv, , Ukraine
City Policlinic #9
Kharkiv, , Ukraine
City Hospital Named After Tropins, Therapy Department #1
Kherson, , Ukraine
OK Clinic
Kyiv, , Ukraine
Medical Center "Consilium Medical"
Kyiv, , Ukraine
Emergency Care Hospital, #1 Therapeutic Department
Lviv, , Ukraine
Regional Hospital, Department of General Surgery
Odesa, , Ukraine
1st City Clinical Hospital, Therapeutic Department
Poltava, , Ukraine
City Clinical Hospital #1, Gastroenterology Department
Vinnytsia, , Ukraine
Medical Centre Diaservis
Zaporizhia, , Ukraine
Countries
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References
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Hart PA, Osypchuk Y, Hovbakh I, Shah RJ, Nieto J, Cote GA, Avgaitis S, Kremzer O, Buxbaum J, Inamdar S, Fass R, Phillips RW, Yadav D, Ladd AM, Al-Assi MT, Gardner T, Conwell DL, Irani S, Sheikh A, Nuttall J; TACTIC Study Investigators. A Randomized Controlled Phase 2 Dose-Finding Trial to Evaluate the Efficacy and Safety of Camostat in the Treatment of Painful Chronic Pancreatitis: The TACTIC Study. Gastroenterology. 2024 Apr;166(4):658-666.e6. doi: 10.1053/j.gastro.2023.12.008. Epub 2023 Dec 15.
Ramsey ML, Nuttall J, Hart PA; TACTIC Investigative Team. A phase 1/2 trial to evaluate the pharmacokinetics, safety, and efficacy of NI-03 in patients with chronic pancreatitis: study protocol for a randomized controlled trial on the assessment of camostat treatment in chronic pancreatitis (TACTIC). Trials. 2019 Aug 14;20(1):501. doi: 10.1186/s13063-019-3606-y.
Other Identifiers
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NI03-001
Identifier Type: -
Identifier Source: org_study_id