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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation (IBS-C)

In brief

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)

Key facts

Study ID

NCT02495623

Run by

Theriva Biologics, Inc.

People needed

63

Starts

2015-06-01

Expected to finish

2015-11-01

Last updated by the study team

2018-11-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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