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

NCT ID: NCT00660335

Last Updated: 2009-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-10-31

Brief Summary

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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

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Conditions

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Pancreatitis

Keywords

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secretin, RG1068, MRCP, pancreas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RG1068 (synthetic human secretin)

Intervention Type DRUG

Single-dose, IV infusion

Interventions

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RG1068 (synthetic human secretin)

Single-dose, IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Repligen Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Repligen Corporation

Principal Investigators

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David R Jacoby, MD, PhD

Role: STUDY_DIRECTOR

Repligen Corporation

References

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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.

Reference Type DERIVED
PMID: 24906040 (View on PubMed)

Other Identifiers

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RG1068-16

Identifier Type: -

Identifier Source: org_study_id