Trials / Completed
CompletedNCT01087801
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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- ChiRhoClin, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ChiRhoStim | Human Secretin for Injection |
| DRUG | Placebo | Saline for Injection |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-11-01
- Completion
- 2009-12-01
- First posted
- 2010-03-16
- Last updated
- 2011-12-06
- Results posted
- 2011-12-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01087801. Inclusion in this directory is not an endorsement.