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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00660335

Enrollment

258

Registered

2008-04-17

Start date

2008-03-31

Completion date

2009-10-31

Last updated

2009-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis

Keywords

secretin, RG1068, MRCP, pancreas

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.

Interventions

DRUGRG1068 (synthetic human secretin)

Single-dose, IV infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The secondary outcome measure will assess safety	up to 30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026