A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
• Interventions: Drug: SYN-010

• Registration Number: NCT02493036
• Lead Sponsor: Theriva Biologics, Inc.

Brief 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

Detailed Description

This is a Phase 2, multi-center, open-label study. Up to sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. Subjects must have completed the previous SB-2-010-001 study. The entire duration of the study may be up to 57 days (from enrollment to the post end-of-study \[EOS\] visit telephone call).

Study Timeline

• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-09
• Study Start: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-01-18
• Results First Posted: 2017-03-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Dose SYN-010	SYN-010	42-mg SYN-010

Primary Outcome Measures

Name	Time	Method
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.	56 days