Skip to main content
OpenTrials
Completed

NCT Number: 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 Irritable Bowel Syndrome with Constipation (IBS-C)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miami, Florida, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have IBS-C and have a positive breath CH4 test result (> 10 ppm) at Screening.
  • Subject must meet the modified Rome III criteria for IBS-C.
  • Subject must have an average abdominal pain intensity score of ≥ 3 (scale 0-10) reported at Screening and Baseline.
  • Subject must have an average of fewer than 3 complete spontaneous bowel movement (CSBMs) per week.
  • 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 currently has any structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility, or any unexplained and clinically significant symptoms such as lower GI bleeding, rectal bleeding, heme-positive stool, iron-deficiency anemia, weight loss, or systemic signs of infection.
  • Subject has been diagnosed with or has a family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
  • Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score of 6 or 7).

Treatment and study plan

SYN-010 21 mg

Drug

SYN-010 42 mg

Drug

Placebo

Drug

Primary outcomes

  1. Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Theriva Biologics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2015
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.