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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: Completed NA study, sponsored by Augusta University.
NCT02078323 is a NA study that has completed, run by Augusta University. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A rectal catheter will be inserted into the rectum, up to 10 cm from the anal verge. The threshold for first sensation and pain will be determined by increasing the electrical stimulation in steps of 1 mA. subsequent stimuli will be applied at an intensity of 75% of the difference between the first sensation and pain thresholds. The CEPs will be recorded in a quiet room in a semi-recumbent position. Four runs of 50 stimuli will be averaged for both the rectal and anal stimulation studies, with a
Interventions
- DRUG Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-07-20 |
| Phase | NA |
What the finished NCT02078323 record still lists
NCT02078323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02078323 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02078323's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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