Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
Information source: Repligen Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatitis
Intervention: RG1068 (synthetic human secretin) (Drug)
Phase: Phase 3
Status: Enrolling by invitation
Sponsored by: Repligen Corporation Official(s) and/or principal investigator(s):
David R Jacoby, MD, PhD, Study Director, Affiliation: Repligen Corporation
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.
Clinical Details
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
Study design: Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: The secondary outcome measure will assess safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: March 2008
Ending date: December 2008
Last updated: April 16, 2008
|
