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NCT03763175 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of SYN-010 in IBS-C
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT03763175: Clinical Trial Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT03763175 is a Phase 2 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03763175, a Phase 2 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
Irritable bowel syndrome (IBS) is a gastrointestinal (GI) syndrome characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. The symptoms of IBS not only adversely affect a patient's health-related quality of life (QoL), but also place a significant financial burden on society due to reduced work productivity and increased use of healthcare-related resources. Patients with IBS frequently complain of abdominal bloating and increased gas production in the form of flatulence or belching. The prevalence in North America and Europe is approximately 10-15%. Irritable bowel syndrome affects all ages and genders however there is a 2:1 female predominance in North America. Irritable bowel syndrome is classified into 4 subtypes based on stool pattern: IBS with constipation (IBS-C), IBS with diarrhea, mixed IBS, and un-subtyped IBS. Irritable bowel syndrome with constipation is defined as the presence of hard or lumpy stools with ≥ 25 percent of bowel movements and loose or watery stools with \< 25% of bowel movements. SYN-010 is a modified release, oral formulation of lovastatin being developed for the treatment of IBS-C. The SYN-010 program is based predominantly on research by Dr. Mark Pimentel and collaborators hypothesizing that reduction in intestinal methane (methane) production can reverse constipation and improve global symptoms in IBS-C. Methane production in humans is due to methanogenic archaea in the intestine, predominantly Methanobrevibacter smithii (M. smithii). Methane, the key product of anaerobic respiration of methanogens, had been perceived to produce no ill effects in humans aside from gaseous distention. However, several research groups worldwide have shown that a significant percentage of patients with IBS-C excrete methane, and elevated methane production by methanogens correlates with constipation and related symptoms in both IBS-C and chronic idiopathic constipation. A direct causative role for methane in
Primary Outcome
Subjects will record their daily bowel movements throughout the duration of the study. Change in weekly average number of CSBMs will be evaluated by comparing reported values pre- and post-treatment.
Interventions
- DRUG Placebo
- DRUG SYN-010 21 mg
- DRUG SYN-010 42 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-12-24 |
| Est. Completion | 2020-10-09 |
| Phase | Phase 2 |
Why NCT03763175 stopped before completion
NCT03763175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03763175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03763175 about?
NCT03763175 is a clinical study titled "Efficacy and Safety of SYN-010 in IBS-C". Irritable bowel syndrome (IBS) is a gastrointestinal (GI) syndrome characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. The symptoms of IBS not only adversely affect a patient's health-related quality of life (QoL), but also place a significant financ...
What is the current status of trial NCT03763175?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2018-12-24. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT03763175?
The interventions under investigation include: Placebo (DRUG), SYN-010 21 mg (DRUG), SYN-010 42 mg (DRUG).
Who is sponsoring clinical trial NCT03763175?
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 NCT03763175's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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