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

This study is enrolling participants by invitation only.

First Received: April 15, 2008 Last Updated: January 29, 2009 History of Changes

Sponsored by:	Repligen Corporation
Information provided by:	Repligen Corporation
ClinicalTrials.gov Identifier:	NCT00660335

Purpose

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	Intervention	Phase
Pancreatitis	Drug: RG1068 (synthetic human secretin)	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Human secretin Secretin

U.S. FDA Resources

Further study details as provided by Repligen Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome measure will assess safety [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: RG1068 (synthetic human secretin) Single-dose, IV infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660335

Sponsors and Collaborators

Repligen Corporation

Investigators

Study Director:

David R Jacoby, MD, PhD

Repligen Corporation

More Information

No publications provided

Responsible Party:	Repligen Corporation ( Melinda Livingstone )
Study ID Numbers:	RG1068-16
Study First Received:	April 15, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00660335 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Repligen Corporation:

secretin, RG1068, MRCP, pancreas

Study placed in the following topic categories:

Secretin
Digestive System Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pancreatic Diseases
Congenital Abnormalities

Hormones
Pancrelipase
Recurrence
Pancreatitis
Pancreatitis, Chronic

Additional relevant MeSH terms:

Secretin
Digestive System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Gastrointestinal Agents
Pancreatic Diseases
Hormones
Pharmacologic Actions
Pancreatitis

ClinicalTrials.gov processed this record on September 11, 2009