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NCT02078323 · ClinicalTrials.gov registry record · NA
Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients
A NA study, sponsored by Augusta University.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT02078323 is a NA study that has completed, run by Augusta University. The registered enrollment target is 39 participants.
The verdict
NCT02078323, a NA study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to understand how a drug called Linaclotide improves bowel function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation (IBS-C) as well as to examine whether Linaclotide alters communication between the brain and pelvic-floor region. Linaclotide has been shown to improve abdominal pain and bowel symptoms in IBS-C, and is approved by the FDA for the treatment of this condition. However, how exactly this drug works to relieve abdominal pain and discomfort in humans is not clearly known. Studies in animal models suggest that patients with IBS-C have hypersensitivity in the gut. Consequently, in IBS-C patients, there is rapid and excessive conduction of signals both from the brain and central nervous system region towards the pelvic-floor (anorectal axis) and the reverse direction. The investigators hypothesize that treatment with Linaclotide may improve/normalize these signals and thereby improve bowel symptoms. Investigators will test this theory using a new, noninvasive (and established) method of studying this communication pathway between the brain and gut.
Interventions
- DRUG Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-07-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02078323
The ClinicalTrials.gov registry entry for NCT02078323 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02078323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02078323 about?
NCT02078323 is a clinical study titled "Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients". The purpose of this study is to understand how a drug called Linaclotide improves bowel function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation (IBS-C) as well as to examine whether Linaclotide alters communication between the brain and pelvic-floor region. Linacloti...
What is the current status of trial NCT02078323?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2014-02. Estimated completion is 2018-07-20.
What interventions are being tested in trial NCT02078323?
The interventions under investigation include: Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT02078323?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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