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

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

Official title:
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

Clinical Trial 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)

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Constipation
Irritable Bowel Syndrome
Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical Trial Details

NCT number	NCT02495623
Study type	Interventional
Source	Synthetic Biologics Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	June 2015
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03471728` - Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
Recruiting	`NCT05643534` - Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years	Phase 3
Recruiting	`NCT05240521` - Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C	N/A
Completed	`NCT01880424` - A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)	Phase 3
Completed	`NCT02078323` - Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients	N/A
Enrolling by invitation	`NCT05905926` - Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C	Phase 3