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

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

January 29, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00660335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Pancreatitis

Intervention ^ICMJE

Drug: RG1068 (synthetic human secretin)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

270

Estimated Completion Date

September 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00660335

Responsible Party

Melinda Livingstone, Repligen Corporation

Study ID Numbers ^ICMJE

RG1068-16

Study Sponsor ^ICMJE

Repligen Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

David R Jacoby, MD, PhD

Repligen Corporation

Information Provided By

Repligen Corporation

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP