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

Pancreatitis Clinical Trial

Official title:

Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)- Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects With a History of Acute or Acute Recurrent Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660335
• Other study ID #: RG1068-16
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2008
• Last updated: December 2, 2009
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: Repligen Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• RG1068 (synthetic human secretin)
Single-dose, IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Repligen Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary outcome measure will assess safety		up to 30 days	No