Clinical Trials Logo

Clinical Trial Summary

This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new medication is called MS1819 Spray Dried (MS1819-SD) which is a lipase produced by the LIP2 gene of Yarrowia lipolytica using recombinant DNA technology.

The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss.

The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods.

The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of patient participation in the study is of 74-93 days.

Approximately twelve patients will be enrolled in this study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03481803
Study type Interventional
Source AzurRx SAS
Contact
Status Completed
Phase Phase 2
Start date January 27, 2017
Completion date June 29, 2018

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 NCT05764629 - An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
Active, not recruiting NCT05042284 - Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis N/A
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 NCT01430234 - Enzyme Suppletion in Exocrine Pancreatic Dysfunction Phase 4
Completed NCT01318369 - Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain Phase 2
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