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

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495623
• Other study ID #: SB-2-010-001
• Status: Completed
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: October 2018
• Source: Synthetic Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation (IBS-C)

Intervention

Drug:
• SYN-010 21 mg

• SYN-010 42 mg

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synthetic Biologics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7		7 days