drugset / Trial / NCT01087801

A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

NCT01087801

Phase 3 Completed 64 enrolled ChiRhoClin, Inc.
RandomizedParallel-groupTriple-blindDiagnostic

Summary

The following are the study hypothesis: * Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates. * Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.

Timeline

Start
2007-10
Primary completion
2009-11
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Secretin Other / unclassified Intravenous

Indications