Overview

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

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Synthetic Biologics Inc.
Criteria
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).