Phase 2
Completed N=54
A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C
Irritable Bowel Syndrome With Constipation (IBS-C)
Source: ClinicalTrials.gov NCT02493036 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose. — 73.78; 63.91; 33.30 ppm*hr
Summary
A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients with Irritable Bowel Syndrome with Constipation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose. |
73.78; 63.91; 33.30 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed Study SB-2-010-001.
- Subject must be willing to abstain from or discontinue the use of any laxatives and any prescription and over-the-counter medications or supplements intended to treat constipation from the time of Screening to the end of the study, except as permitted in this protocol.
- Subject must agree to refrain from making any lifestyle changes that may affect IBS-C symptoms from the time of Screening to the end of the study.
Exclusion Criteria
- Subject has taken IBS treatments (prescription or over-the-counter), proton pump inhibitors, laxatives, antibiotics.
- Subject did not complete Study SB-2-010-001 or more than 7 days have elapsed since the subject's last dose of study drug in that study.
- Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score of 6 or 7) in the absence of any laxative, or has a BSFS score of 6 for more than 1 spontaneous bowel movement (SBM) or a BSFS score of 7 for any SBM during the last 7 days of diary reporting for Study SB-2-010-001.
- Subject has any abnormal laboratory results, electrocardiogram (ECG) findings, or physical examination findings deemed clinically significant by the investigator at the Study SB-2-010-001 End-of-Study Visit.
Data sourced from ClinicalTrials.gov (NCT02493036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.