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

R

Repligen

Status and phase

Completed
Phase 3

Conditions

Pancreatitis

Treatments

Drug: RG1068 (synthetic human secretin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00660335
RG1068-16

Details and patient eligibility

About

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.

Enrollment

258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

258 participants in 1 patient group

1
Experimental group
Treatment:
Drug: RG1068 (synthetic human secretin)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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