Chronic PancreatitisPhase 1/2TacticNCT02693093
A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
A Phase 1/2 study testing NI-03 in people with Chronic Pancreatitis, run by Kangen Pharmaceuticals, Inc at 48 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of NI-03. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- NI-03
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 48 sitesin 3 countries
- Study dates
- 24 Feb 2016to 30 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 19Show fewer
- 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
Trial locations and contacts
48 sites in 3 countries.
48 sites in 3 countries
United States28 sites
Texas Clinical Research Institute
Arlington, Texas, 76012
University of Colorado-Div of Gastroenterology and Hepatology
Aurora, Colorado, 80045
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
MetroHealth Medical Center
Cleveland, Ohio, 44109
Ohio State University (OSU) - Wexner Medical Center
Columbus, Ohio, 43210
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
University of Florida - Division of Gastroenterology
Gainesville, Florida, 32608
Baylor College of Medicine
Houston, Texas, 77030
Indiana University - Indiana University Hospital
Indianapolis, Indiana, 46202-5149
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Borland-Groover Clinic
Jacksonville, Florida, 32256
Kansas City Research Institute
Kansas City, Missouri, 64131
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
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
Wisconsin Center for Advanced Research, a division of GI Associates LLC
Milwaukee, Wisconsin, 53215
Gastroenterology Group of Naples
Naples, Florida, 34102
Yale School of Medicine
New Haven, Connecticut, 06519
Columbia University School of Medicine
New York, New York, 10027
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2536
Virginia Mason
Seattle, Washington, 98101
Stanford University School of Medicine
Stanford, California, 94305
The Carle Foundation Hospital
Urbana, Illinois, 61801
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519
Ukraine12 sites
Institute of Gastroenterology
Dnipro, 49074
Central city Clinical Hospital, Therapeutic Department #2
Ivano-Frankivsk, 76018
Malaya Therapy National Institute
Kharkiv, 61039
City Policlinic #9
Kharkiv, 61172
City Hospital Named After Tropins, Therapy Department #1
Kherson, 73000
OK Clinic
Kyiv, 02091
Medical Center "Consilium Medical"
Kyiv, 04050
Emergency Care Hospital, #1 Therapeutic Department
Lviv, 79059
Regional Hospital, Department of General Surgery
Odesa, 65025
1st City Clinical Hospital, Therapeutic Department
Poltava, 36038
City Clinical Hospital #1, Gastroenterology Department
Vinnytsia, 21029
Medical Centre Diaservis
Zaporizhia, 69076
Russia8 sites
Federal Research Centre Institute of Cytology and Genetics
Novosibirsk, 630089
Military Medical Academu, Dep of Therapy of Adv. Training
Saint Petersburg, 191015
Military Medical Academy, Department of Hospital Therapy
Saint Petersburg, 191124
1st Saint Petersburg State Medical University
Saint Petersburg, 197022
City Hospital #40
Saint Petersburg, 197706
City Polyclinic #4
Saint Petersburg, 199178
Medical University "Reaviz"
Samara, 443011
Tomsk Regional Clinical Hospital
Tomsk, 634063
About this study
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
The purpose of this study is to determine the safety and efficacy of NI-03.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- NI-03, Placebo
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NI-03Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | TID Day for 28 Days Receives: Drug: Placebo |
| 100 mg NI-03 | Experimental | TID Day for 28 Days Receives: Drug: NI-03 |
| 200 mg NI-03 | Experimental | TID Day for 28 Days Receives: Drug: NI-03 |
| 300 mg NI-03 | Experimental | TID Day for 28 Days Receives: Drug: NI-03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA
Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution (Vz/F) are assessed.
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose
Phase 1 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through 7 days post-dose
Phase 1 - Safety and Tolerability - Laboratory test results
Laboratory test results will be graded and summarized based on CTCAE v4.03. and by shifts in results before and after dosing
Measured: through 7 days post-dose
Phase 2 - Efficacy Analysis - average daily worst pain intensity score
Measured: 4 Weeks
Secondary outcomes (19)
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - Maximum concentration (Cmax)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - time to maximum plasma concentration (tmax)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent clearance (CL/F)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - plasma terminal half-life (t1/2)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent volume of distribution (Vz/F)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 2 - Efficacy Analysis - Change from baseline in least pain score
Measured: change from baseline to Week 4
Phase 2 - Efficacy Analysis - Change from baseline in average pain score
Measured: 4 Weeks
Phase 2 - Efficacy Analysis - Change from baseline in current pain score
Measured: 4 Weeks
Phase 2 - Efficacy Analysis - Change from baseline in average morphine-equivalent daily opioid daily dose
Measured: 4 Weeks
Phase 2 - Efficacy Analysis - Change from baseline in quality of life
assessed using the pain interference aspects of the Brief Pain Inventory (BPI)
Measured: change from baseline to Week 4
Phase 2 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Through day 57 (End of Study Visit)
Phase 2 - Safety and tolerability - Laboratory Test Results
Laboratory test results will be graded and summarized based on CTCAE v4.03. and by shifts in results before and after dosing
Measured: Through day 57 (End of Study Visit)
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC)
Measured: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - Maximum concentration (Cmax)
Measured: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - time to maximum plasma concentration (tmax)
Measured: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - plasma terminal half-life (t1/2)
Measured: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent clearance (CL/F)
Measured: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent volume of distribution (Vz/F)
Measured: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start24 Feb 2016
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangen Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phiip Hart, MD, Principal investigator, OSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693093
- Sponsor's protocol ID
- NI03-001
- Acronym
- Tactic
- Status last verified
- Dec 2022
- First submitted
- 12 Feb 2016
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38103842Ramsey 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.
PubMed 31412955
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02693093
- Acronym / sponsor ID
- Tactic / NI03-001
- Conditions
- Chronic Pancreatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Kangen Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of NI-03.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboTID Day for 28 Days |
| 100 mg NI-03 | Experimental | Drug: NI-03TID Day for 28 Days |
| 200 mg NI-03 | Experimental | Drug: NI-03TID Day for 28 Days |
| 300 mg NI-03 | Experimental | Drug: NI-03TID Day for 28 Days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NI-03 | Drug | 100 mg NI-03, 200 mg NI-03, 300 mg NI-03 |
| Placebo | Drug | placebo |
Primary outcome
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose
Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution (Vz/F) are assessed.
Phase 1 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0
Time frame: through 7 days post-dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Phase 1 - Safety and Tolerability - Laboratory test results
Time frame: through 7 days post-dose
Laboratory test results will be graded and summarized based on CTCAE v4.03. and by shifts in results before and after dosing
Phase 2 - Efficacy Analysis - average daily worst pain intensity score
Time frame: 4 Weeks
19 secondary outcomes
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - Maximum concentration (Cmax)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - time to maximum plasma concentration (tmax)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent clearance (CL/F)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - plasma terminal half-life (t1/2)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent volume of distribution (Vz/F)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 2 - Efficacy Analysis - Change from baseline in least pain score
Time frame: change from baseline to Week 4
Phase 2 - Efficacy Analysis - Change from baseline in average pain score
Time frame: 4 Weeks
Phase 2 - Efficacy Analysis - Change from baseline in current pain score
Time frame: 4 Weeks
Phase 2 - Efficacy Analysis - Change from baseline in average morphine-equivalent daily opioid daily dose
Time frame: 4 Weeks
Phase 2 - Efficacy Analysis - Change from baseline in quality of life
Time frame: change from baseline to Week 4
Phase 2 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0
Time frame: Through day 57 (End of Study Visit)
Phase 2 - Safety and tolerability - Laboratory Test Results
Time frame: Through day 57 (End of Study Visit)
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC)
Time frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - Maximum concentration (Cmax)
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose.
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - time to maximum plasma concentration (tmax)
Time frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - plasma terminal half-life (t1/2)
Time frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent clearance (CL/F)
Time frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent volume of distribution (Vz/F)
Time frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Derived from this study: PubMed 38103842Hart 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.
- Derived from this study: PubMed 31412955Ramsey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phiip Hart, MD principal investigator
OSU
48 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NI-03 in people with Chronic Pancreatitis, run by Kangen Pharmaceuticals, Inc at 48 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Ukraine, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA (time frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.