NCT00660335

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

Enrollment Period

1.6 years

First QC Date

April 15, 2008

Last Update Submit

December 2, 2009

Conditions

Pancreatitis

Keywords

secretin, RG1068, MRCP, pancreas

Outcome Measures

Primary Outcomes (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.

    0 - 10 minutes post dose

Secondary Outcomes (1)

  • The secondary outcome measure will assess safety

    up to 30 days

Study Arms (1)

1

EXPERIMENTAL
Drug: RG1068 (synthetic human secretin)

Interventions

RG1068 (synthetic human secretin)DRUG

Single-dose, IV infusion

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of pancreatitis
  • Medically stable
  • Able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sherman S, Freeman ML, Tarnasky PR, Wilcox CM, Kulkarni A, Aisen AM, Jacoby D, Kozarek RA. Administration of secretin (RG1068) increases the sensitivity of detection of duct abnormalities by magnetic resonance cholangiopancreatography in patients with pancreatitis. Gastroenterology. 2014 Sep;147(3):646-654.e2. doi: 10.1053/j.gastro.2014.05.035. Epub 2014 Jun 4.

    PMID: 24906040DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • David R Jacoby, MD, PhD

    Repligen Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 3, 2009

Record last verified: 2009-12