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

NCT02495623 | Completed Phase 2 Results

• 1 other identifier: SB-2-010-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Outcome Measures

Primary Outcomes (1)

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

  7 days

Study Arms (3)

Low Dose

ACTIVE COMPARATOR

21 mg SYN-010

Drug: SYN-010 21 mg

High Dose

ACTIVE COMPARATOR

42 mg SYN-010

Drug: SYN-010 42 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SYN-010 21 mg DRUG

Low Dose

SYN-010 42 mg DRUG

High Dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Theriva Biologics, Inc.: lead

Study Sites (1)

Unknown Facility

Miami, Florida, United States

Location

Results Point of Contact

• Title: Michael Kaleko
• Organization: Synthetic Biologics Inc

mkaleko@syntheticbiologics.com

(240) 238-3862

Study Officials

• Michael Kaleko, M.D.

  Synthetic Biologics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 13, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 27, 2018
• Results First Posted: March 8, 2017

Record last verified: 2018-10

Locations

US (1)