DRUG
RG1068 (synthetic human secretin)
Single-dose, IV infusion
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
Status
Completed
Phase
Phase 3
Enrollment
258
Locations
0
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 17, 2008
Study start
Mar 2008
Primary completion
Oct 2009
Study completion
Oct 2009
Results posted
Not reported
Registry updated
Dec 3, 2009
Outcomes
What the study measures.
Primary outcomes
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.
Time frame · 0 - 10 minutes post dose
Secondary outcomes
The secondary outcome measure will assess safety
Time frame · up to 30 days
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
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Related PeptideStat pages
Put the record in context.
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