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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00660335
Other study ID # RG1068-16
Secondary ID
Status Completed
Phase Phase 3
First received April 15, 2008
Last updated December 2, 2009
Start date March 2008
Est. completion date October 2009

Study information

Verified date December 2009
Source Repligen Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
RG1068 (synthetic human secretin)
Single-dose, IV infusion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Repligen Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary The secondary outcome measure will assess safety up to 30 days No
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