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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 is a Phase 2 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 59 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03763175
The ClinicalTrials.gov registry entry for NCT03763175 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03763175 reports 0 study locations.
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.
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