Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

To be eligible to participate in this study, subjects must meet all of the following criteria at Screening:

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

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

To be eligible to participate in this study, subjects must not meet any of the following 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
placebo
TID Day for 28 Days
  • Drug: Placebo
Experimental
100 mg NI-03
TID Day for 28 Days
  • Drug: NI-03
Experimental
200 mg NI-03
TID Day for 28 Days
  • Drug: NI-03
Experimental
300 mg NI-03
TID Day for 28 Days
  • Drug: NI-03

Recruiting Locations

University of Arkansas
Little Rock, Arkansas 72204
Contact:
Diana Gregory
501-526-7685
dgregory@uams.edu

Kaiser Permanente Medical Group
Los Angeles, California 90027
Contact:
Olivia Bravo
323-738-1542
olivia.bravo@kp.org

University of Southern California, Keck School of Medicine
Los Angeles, California 90033
Contact:
Jessica Serna
323-409-6939
sernaj@usc.edu

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Liliana Bancila
310-423-3872
liliana.bancila@cshs.org

Stanford University School of Medicine*
Stanford, California 94305
Contact:
Judith Chang
650-724-1336
judithcc@stanford.edu

University of Colorado-Div of Gastroenterology and Hepatology
Aurora, Colorado 80045
Contact:
Angelina Miley
303-724-9228
angelina.miley@cuanschutz.edu

Yale School of Medicine
New Haven, Connecticut 06519
Contact:
Christina Rose
christina.rose@yale.edu

University of Florida - Division of Gastroenterology
Gainesville, Florida 32608
Contact:
Tiffany Harrison
352-265-8982
Tiffany.Harrison@medicine.ufl.edu

Borland-Groover Clinic
Jacksonville, Florida
Contact:
Twila Morrell
tmorrell@encoredocs.com

Gastroenterology Group of Naples
Naples, Florida 34102
Contact:
Paula Allain
pallainresearch@gmail.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Christine Canfield
217-326-0080
christine.canfield@carle.com

Indiana University - Indiana University Hospital
Indianapolis, Indiana 46202-5149
Contact:
Gail McNulty
317-948-3684
gmcnulty@iu.edu

Johns Hopkins Medicine
Baltimore, Maryland 21205
Contact:
Mahya Faghih
443-761-9157
Mfaghih2@jhu.edu

UMass Memorial Medical Center
Worcester, Massachusetts 01605
Contact:
Karen Gallagher-Dorval
508-856-2857
Karen.gallagher-dorval@umassmed.edu

Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan 48047
Contact:
Joe Palmer
586-598-3329
jpalmer@researchmi.com

Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
Contact:
Bridgett Klooster
616-608-8738
bklooster@gastro-assoc-wm.com

Kansas City Research Institute
Kansas City, Missouri 64131
Contact:
Kelly Vargas
816-759-5274
kvargas@kcresearchinstitute.com

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Tracy Ostler
Tracy.L.Ostler@hitchcock.org

Columbia University School of Medicine
New York, New York 10027
Contact:
Emil Agarunov
212-342-3781
ea2715@CUMC.Columbia.edu

PMG Research of Winston-Salem
Winston-Salem, North Carolina 27103
Contact:
Sydney Navy
336-768-8062
Sydney.navy@pmg-research.com

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Kristine Russ
216-778-5278
kruss@metrohealth.org

Ohio State University (OSU) - Wexner Medical Center
Columbus, Ohio 43210
Contact:
Brianna Conley
614-366-4495
brianna.conley@osumc.edu

UPMC Presbyterian
Pittsburgh, Pennsylvania 15213-2536
Contact:
Kelley Wood
412-648-7442
etheringtonka@upmc.edu

Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
Contact:
Reshil Dukes
843-792-0387
dukesre@musc.edu

Texas Clinical Research Institute
Arlington, Texas 76012
Contact:
Ian Mumm
817-471-1070
imum@tcri.us

Texas Tech University Health Sciences Center
El Paso, Texas 79905
Contact:
Nancy Casner
915-215-5170
nancy.casner@ttuhsc.edu

Baylor College of Medicine
Houston, Texas 77030
Contact:
Chandra Kovvali
713-798-2308
ckovvali@bcm.edu

Virginia Mason
Seattle, Washington 98101
Contact:
Cheryl Shaw
206-341-1786
Cheryl.shaw@virginiamason.org

Wisconsin Center for Advanced Research, a division of GI Associates LLC
Milwaukee, Wisconsin 53215
Contact:
Kelly Dunneboil
414-908-6630
kellyd@wigia.com

More Details

NCT ID
NCT02693093
Status
Recruiting
Sponsor
Kangen Pharmaceuticals, Inc

Study Contact

Janet Nuttall, M.P.H.
760 438-1722
janet.nuttall@kangenpharma.co.jp

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.