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NCT02661425 · ClinicalTrials.gov registry record
Retrospective Study of IBS-D Patients Previously Receiving SBI
A clinical trial of Diarrhoea Predominant Irritable Bowel Syndrome, sponsored by Entera Health.
- Completed
- Registry status
- 165
- Enrollment target
- 16
- Study locations
NCT02661425: Completed study of Diarrhoea Predominant Irritable Bowel Syndrome, sponsored by Entera Health.
NCT02661425 is a study of Diarrhoea Predominant Irritable Bowel Syndrome that has completed, run by Entera Health. The registered enrollment target is 165 participants. The trial reports 16 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02661425, a study of Diarrhoea Predominant Irritable Bowel Syndrome, has completed, sponsored by Entera Health.
- COMPLETED
- Registry status
- 165 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a retrospective study designed to gather outcomes data from existing medical charts from patients who have taken EnteraGam for management of their IBS-D for at least eight weeks. Data from two study periods will be collected: (1) the time during which the Standard of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the time during which EnteraGam is used as therapy.
Primary Outcome
Data collected from existing medical charts
Conditions Studied
Interventions
- OTHER EnteraGam
Study Locations (16)
Florida
- - Coral Springs
- - Maitland
- - Orlando
- - Tampa
- - Winter Park
Tennessee
- - Kingsport
- - Knoxville
- - Morristown
Connecticut
- - Greenwich
- - Hamdon
New York
- - Lynbrook
- - New York
Georgia
- - Smyrna
Maryland
- - Columbia
Missouri
- - St Louis
Texas
- - Bedford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-09 |
What the finished NCT02661425 record still lists
NCT02661425 is an observational study that tracks outcomes without assigning an intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Diarrhoea Predominant Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which EnteraGam is the first listed.
NCT02661425 lists 16 locations in 8 states (Florida, Tennessee, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02661425 about?
NCT02661425 is a clinical study titled "Retrospective Study of IBS-D Patients Previously Receiving SBI". This is a retrospective study designed to gather outcomes data from existing medical charts from patients who have taken EnteraGam for management of their IBS-D for at least eight weeks. Data from two study periods will be collected: (1) the time during which the Standard of Care (SOC) therapy (i.e....
What is the current status of trial NCT02661425?
This trial is currently completed. The enrollment target is 165 participants. The study started on 2015-12. Estimated completion is 2016-09.
What conditions does trial NCT02661425 study?
This clinical trial studies the following conditions: Diarrhoea Predominant Irritable Bowel Syndrome.
What interventions are being tested in trial NCT02661425?
The interventions under investigation include: EnteraGam (OTHER).
Who is sponsoring clinical trial NCT02661425?
This trial is sponsored by Entera Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02661425 being conducted?
This trial has 16 study locations across Connecticut, Florida, Georgia, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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