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

This study has been completed.
Sponsor:
Information provided by:
Repligen Corporation
ClinicalTrials.gov Identifier:
NCT00660335
First received: April 15, 2008
Last updated: December 2, 2009
Last verified: December 2009
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 258
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Repligen Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melinda Livingstone, Repligen Corporation
ClinicalTrials.gov Identifier: NCT00660335     History of Changes
Other Study ID Numbers: RG1068-16
Study First Received: April 15, 2008
Last Updated: December 2, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Repligen Corporation:
secretin, RG1068, MRCP, pancreas

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014