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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00660335
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : December 3, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: RG1068 (synthetic human secretin) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : March 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: 1 Drug: RG1068 (synthetic human secretin)
Single-dose, IV infusion




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The secondary outcome measure will assess safety [ Time Frame: up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660335


Sponsors and Collaborators
Repligen Corporation
Investigators
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Study Director: David R Jacoby, MD, PhD Repligen Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melinda Livingstone, Repligen Corporation
ClinicalTrials.gov Identifier: NCT00660335    
Other Study ID Numbers: RG1068-16
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009
Keywords provided by Repligen Corporation:
secretin, RG1068, MRCP, pancreas
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs