CompletedPhase 3

Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas

258 participantsStarted 2008-03

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * History of pancreatitis * Medically stable * Able to give informed consent Exclusion Criteria: * Prior history of pancreatic resection * Prior history of pancreatic duct drainage procedure * Presence of a pancreatic stent * Unstable cardiovascular disease * Any contraindication to MRI procedure * Pregnancy

What they're measuring

The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.

Timeframe: 0 - 10 minutes post dose

Trial details

NCT IDNCT00660335

SponsorRepligen Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

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