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.

Start Date24 Feb 2016

Sponsor / Collaborator

Kangen Pharmaceuticals Co. Ltd.

100 Clinical Results associated with NI-03

100 Translational Medicine associated with NI-03

100 Patents (Medical) associated with NI-03

Literatures (Medical) associated with NI-03

01 Dec 2019·Trials

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

Author: Ramsey, Mitchell L ; Nuttall, Janet ; Hart, Phil A

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.DISCUSSIONNI-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.

04 Aug 2016·Wei sheng wu xue bao = Acta microbiologica Sinica

[Effects of nisin on in vitro fermentation, methanogenesis and functional microbial populations of the rumen].

Article

Author: Chen, Yaying ; Zhu, Weiyun ; Liu, Zhuang ; Shen, Junshi ; Lv, Peng'an

ObjectiveThis study was conducted to evaluate the effects of nisin on in vitro fermentation, methanogenesis and functional microbial populations of the rumen.MethodsThe negative control did not contain any additives. Monensin (5 μmol/L) was added as positive control. Nisin was added at 3 doses:3 (NI-3), 9 (NI-9), and 27 mg/100 mL (NI-27). Each treatment contained 4 replicates. Gas and methane production was measured at 0, 3, 6, 9, 12, and 24 h after incubation. Samples of culture were collected at 24 h, and used to measure rumen fermentation parameters and functional microbial populations.ResultsCompared with negative control, both nisin and monensin addition dramatically reduced gas and methane production (P<0.05). Nisin addition had no effect on pH, dry matter degradability, and organic matter degradability (P0.05). Ammonia concentration was reduced by NI-9 (P<0.05), but was not influenced by NI-3 and NI-27 (P0.05). In contrast, monensin addition significantly lowered dry matter degradability, organic matter degradability, and ammonia concentration (P<0.05), but had no influence on pH (P0.05). Compared with negative control, both nisin and monensin addition significantly reduced acetate concentration and acetate-propionate ratio (P<0.05), and increased propionate concentration (P<0.05). Quantitative real-time PCR results showed that both nisin and monensin addition had no effects on the populations of total bacteria and Bacteroides (P0.05). Compared with negative control, the populations of protozoa, methanogens, fungi and Firmicutes were not influenced by nisin (P0.05), but were significantly reduced by monensin addition (P<0.05). Both nisin and monensin addition significantly increased the populations of sulfur-reducing bacteria and Clostridium aminophilum (P<0.05), but had no influence on the population of Clostridium sticklandii (P0.05).ConclusionAppropriate nisin addition could reduce methanogenesis and ammoniagenesis, while had no adverse effect on feed digestion. These effects are probably associated with the variation of rumen functional microbial populations and communities.

01 Jan 2014·Tierärztliche Praxis Ausgabe G: Großtiere / NutztiereQ4 · AGRICULTURAL & FORESTRY SCIENCE

Einsatz von Gonadorelin[6-D-Phe] am Tag 0 oder 12 post inseminationem zur Steigerung der Konzeptionsrate in einer sächsischen Milchviehgroßanlage

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Passarge, O ; Weber, O ; Freick, M ; Neubert, T

100 Deals associated with NI-03

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pancreatitis	Phase 2	-	Stason Industrial Corp.	-
Pancreatitis, Chronic	Discovery	RU	Kangen Pharmaceuticals Co. Ltd.	01 Dec 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

NI-03

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation