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

December 2, 2009 updated by: Repligen Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: RG1068 (synthetic human secretin)
Single-dose, IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0 - 10 minutes post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome measure will assess safety
Time Frame: up to 30 days
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repligen Corporation

Investigators

  • Study Director: David R Jacoby, MD, PhD, Repligen Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (ESTIMATE)

April 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2009

Last Update Submitted That Met QC Criteria

December 2, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1068-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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