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

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)

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258 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RG1068 (synthetic human secretin)