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 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)

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
• Intervention / Treatment: Drug: Placebo; Drug: SYN-010 21 mg; Drug: SYN-010 42 mg

Detailed 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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Active Comparator: Low Dose; 21 mg SYN-010	Drug: SYN-010 21 mg
Active Comparator: High Dose; 42 mg SYN-010	Drug: SYN-010 42 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7	7 days

Collaborators and Investigators

• Sponsor: Synthetic Biologics Inc.
• Investigators: Study Director: Michael Kaleko, M.D., Synthetic Biologics

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: SB-2-010-001