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

Phase 3

Completed

• Conditions: Pancreatitis
• Interventions: Drug: RG1068 (synthetic human secretin)

• Registration Number: NCT00660335
• Lead Sponsor: Repligen Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-02
• Last Update Posted: 2009-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	RG1068 (synthetic human secretin)	-

Primary Outcome Measures

Name	Time	Method
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.	0 - 10 minutes post dose

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measure will assess safety	up to 30 days