Status:

COMPLETED

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

Lead Sponsor:

Repligen Corporation

Conditions:

Pancreatitis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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.

Eligibility Criteria

Inclusion

  • History of pancreatitis
  • Medically stable
  • Able to give informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

258 Patients enrolled

Trial Details

Trial ID

NCT00660335

Start Date

March 1 2008

End Date

October 1 2009

Last Update

December 3 2009

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