NCT02495623

A Study of the Effect of SYN-010 on Subjects With IBS-C

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared With Placebo on Breath Methane Production in Breath Methane-Positive Subjects With IBS-C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Theriva Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)

Detailed description

This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. The entire duration of the study may be up to 43 days (from Screening to the post end-of-study \[EOS\] visit telephone call).

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

Type	Name	Description
DRUG	SYN-010 21 mg
DRUG	SYN-010 42 mg
DRUG	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-07-13
• Last updated: 2018-11-27
• Results posted: 2017-03-08

Locations

1 site across 1 country: United States