Clinical Trials Logo
  1. Home
  2. Chronic Pancreatitis
  3. NCT02693093

A Dose Ranging Study Evaluating Efficacy and Safety of NI-03 — Tactic  

Chronic Pancreatitis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02693093
Study type Interventional
Source Kangen Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 24, 2016
Completion date December 30, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03112759 - Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis N/A
Enrolling by invitation NCT05410795 - Establishment and Verification of Pancreatic Volume Formula Based on Imaging
Active, not recruiting NCT02965898 - The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis N/A
Completed NCT02868047 - Establishing Standards for Normal Pancreatic EUS N/A
Completed NCT01452217 - Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers Phase 1
Completed NCT00685087 - A Prospective Study of Natural History of Pancreatitis N/A
Completed NCT04949828 - Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Recruiting NCT06068426 - Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management N/A
Active, not recruiting NCT05042284 - Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis N/A
Active, not recruiting NCT05764629 - An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Recruiting NCT05692596 - The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Recruiting NCT06015945 - Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis N/A
Completed NCT04619511 - Risk Factors for Post-ESWL and Post-ERCP Pancreatitis
Completed NCT03283566 - Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT Phase 2
Recruiting NCT03434392 - QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing N/A
Completed NCT01318369 - Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain Phase 2
Completed NCT01430234 - Enzyme Suppletion in Exocrine Pancreatic Dysfunction Phase 4
Terminated NCT01442454 - Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis N/A
Completed NCT00755573 - Pain and Chronic Pancreatitis - Clinical End Experimental Studies Phase 2/Phase 3