ArticleTrials2019
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).
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02693093 (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), which is not on this map. Cited by 31 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
31 citing papers in PubMed, 58 citations in OpenAlex.
- Phase 2 Open-label, Single-arm, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Camostat Mesylate in Patients with Protein-losing Enteropathy After Fontan Operation.Pediatric cardiology · 2026Trial
- Management of chronic pancreatitis: recent advances and future prospects.Therapeutic advances in gastroenterology · 2024Review
- Quality of life after total pancreatectomy with islet autotransplantation for chronic pancreatitis in Japan.Islets · 2023Article
- A case of early-onset idiopathic chronic pancreatitis associated with a loss-of-function TRPV6 p.R483Q variant successfully treated by pancreatic duct stenting.Clinical journal of gastroenterology · 2023Article
- Potential treatments of COVID-19: Drug repurposing and therapeutic interventions.Journal of pharmacological sciences · 2023Review
- Molecular mechanisms involved in anosmia induced by SARS-CoV-2, with a focus on the transmembrane serine protease TMPRSS2.Archives of virology · 2022Review
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- The Global Status and Trends of Enteropeptidase: A Bibliometric Study.Frontiers in medicine · 2022Article
- Repurpose but also (nano)-reformulate! The potential role of nanomedicine in the battle against SARS-CoV2.Journal of controlled release : official journal of the Controlled Release Society · 2021Review
- COVID-19: Antiviral agents and enzyme inhibitors/receptor blockers in development.Experimental biology and medicine (Maywood, N.J.) · 2021Review
- A Multidisciplinary Approach to Coronavirus Disease (COVID-19).Molecules (Basel, Switzerland) · 2021Review
- Immunoregulatory therapy strategies that target cytokine storms in patients with COVID-19 (Review).Experimental and therapeutic medicine · 2021Review
- A comparative analysis of remdesivir and other repurposed antivirals against SARS-CoV-2.EMBO molecular medicine · 2021Review
- Therapeutically effective covalent spike protein inhibitors in treatment of SARS-CoV-2.Journal of proteins and proteomics · 2021Review
- Possible therapeutic targets for SARS-CoV-2 infection and COVID-19.Journal of allergy and infectious diseases · 2021Article
- Potential role of interferons in treating COVID-19 patients.International immunopharmacology · 2021Review
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- Coronavirus pandemic: treatment and future prevention.Future microbiology · 2020Article
- Cathepsin L-selective inhibitors: A potentially promising treatment for COVID-19 patients.Pharmacology & therapeutics · 2020Review
- Potential new treatment strategies for COVID-19: is there a role for bromhexine as add-on therapy?Internal and emergency medicine · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
backgroundChronic pancreatitis (CP) is a progressive, fibro-inflammatory disease characterized by enzymatic autoactivation and subsequent fibrotic replacement of acinar cells. A significant proportion of patients develop pain, which may be due to many causes, including perineural inflammation, altered central processing of pain signals, parenchymal structural changes, and ductal obstruction. Currently there are no approved medical treatment options for CP-associated pain. NI-03 (camostat mesilate) is an orally administered serine protease inhibitor that reduces pancreatic enzyme activity and has been widely used for the treatment of CP-associated pain in Japan. The current study will assess the safety and efficacy of NI-03 for reduction of CP-associated pain in the USA.
methodsThe current study consists of two phases. First, a phase I study will be performed to establish the pharmacokinetics and safety profile over a 1-week period following a single dose (100, 200, or 300 mg). Subsequently, a phase II study will be performed consisting of a double-blind, randomized, controlled trial (RCT). This RCT will evaluate the efficacy of each of the three doses of NI-03 given three times daily compared to placebo over 28 days. A 7-day, single-blind, run-in period will precede the double-blind phase to assess baseline pain characteristics. The primary efficacy outcome is the average of worst daily pain scores (numeric rating scale of 0-10) over the terminal 7 days of the study period compared to baseline. Secondary efficacy outcomes include change in opioid dose and quality of life measures, and time to first rescue intravenous analgesic. Adverse events will be recorded. DISCUSSION: NI-03 has been used successfully and safely in Japan to treat CP-associated pain. The aim of the current study is to assess the safety and efficacy of NI-03 using a rigorous RCT in a population in the USA. This study may fill an important clinical gap to provide an effective medical treatment option for CP-associated pain.
trial registrationClinicalTrials.gov, NCT02693093 . Registered through the National Institutes of Health on 26 February 2016.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.