CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
ChiRhoStim +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01087801
NCT01087801Phase 3Completed
CompareCT.gov

A Placebo Controlled, Double-Blind, Parallel, Multicenter Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

ChiRhoClin, Inc.·interventional·Posted Mar 16, 2010·Updated Dec 6, 2011

In Brief

A Phase 3 clinical trial evaluating ChiRhoStim and Placebo for Pancreatic Disease. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2010
Enrollment StartOct 1, 2007
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.3 years ago

Interventions

ChiRhoStimdrug

Human Secretin for Injection

Placebodrug

Saline for Injection