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NCT03462966 · ClinicalTrials.gov registry record · Phase 2
Rifaximin on Visceral Hypersensitivity
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03462966: Clinical Trial Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT03462966 is a Phase 2 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03462966, a Phase 2 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11% according to a recent meta-analysis. The total cost of managing IBS in the United States is in excess of $30 billion per year, including indirect costs relating to loss of productivity of more than $20 billion. Abdominal pain/discomfort (i.e. visceral hypersensitivity) is present in all patients with IBS and remains the most therapy-resistant symptom. Apart from abdominal pain, which is measured subjectively using visual scales, several studies have shown a significant increase in rectal sensitivity, which is measured objectively using an inflatable balloon. Drugs which are shown to have objective effects on visceral hypersensitivity are crucial in the management of IBS. While certain drugs have shown to decrease abdominal pain, there is very little data to substantiate objective changes in visceral hypersensitivity. Rifaximin is a poorly absorbed antibiotic and the exact underlying mechanism of action for rifaximin in reducing the pain component of IBS remains unknown. However, rifaximin has been shown in randomized controlled trials to decrease abdominal discomfort in all subtypes of IBS. The investigators hypothesize that rifaximin is effective in decreasing rectal visceral hypersensitivity in IBS patients. In this study, the investigators propose to test this hypothesis by measuring visceral hypersensitivity using the graded balloon distention test, before and after a course of rifaximin. To test whether this effect is accompanied by treating SIBO, the investigators will also perform lactulose breath tests before and after rifaximin therapy.
Primary Outcome
A 100-cubic centimeter visual analogue scale with verbal descriptors (0=no sensation, 20=first sensation, 40=first sense of urge, 60=normal urge to defecate, 80=severe urge to defecate, and 100=discomfort/pain) will be used to score evoked sensations.
Interventions
- DRUG Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2021-11-19 |
| Phase | Phase 2 |
Why NCT03462966 stopped before completion
NCT03462966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Rifaximin is the first listed.
NCT03462966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03462966 about?
NCT03462966 is a clinical study titled "Rifaximin on Visceral Hypersensitivity". Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11% according to a recent meta-analysis. The total cost of managing IBS in the United States is in excess of $30 billion per year, including indirect costs relating to loss of productivit...
What is the current status of trial NCT03462966?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2018-07-01. Estimated completion is 2021-11-19.
What interventions are being tested in trial NCT03462966?
The interventions under investigation include: Rifaximin (DRUG).
Who is sponsoring clinical trial NCT03462966?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03462966's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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