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

NCT02495623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-11-27

Study results available
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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)

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

DRUG

SYN-010 21 mg

DRUG

SYN-010 42 mg

DRUG

Placebo

Sponsors & Collaborators

  • Theriva Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kaleko, M.D. · Synthetic Biologics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02495623 on ClinicalTrials.gov