A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C

NCT02493036 | Completed Phase 2 Results

• 1 other identifier: SB-2-010-002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 11

Brief Summary

A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients with Irritable Bowel Syndrome with Constipation

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Outcome Measures

Primary Outcomes (1)

• Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose.

  56 days

Study Arms (1)

High Dose SYN-010

EXPERIMENTAL

42-mg SYN-010

Drug: SYN-010

Interventions

SYN-010 DRUG

High Dose SYN-010

Eligibility Criteria

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

You may qualify if:

• Subject has completed Study SB-2-010-001.
• Subject must be willing to abstain from or discontinue the use of any laxatives and any prescription and over-the-counter medications or supplements intended to treat constipation from the time of Screening to the end of the study, except as permitted in this protocol.
• 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 did not complete Study SB-2-010-001 or more than 7 days have elapsed since the subject's last dose of study drug in that study.
• Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale \[BSFS\] score of 6 or 7) in the absence of any laxative, or has a BSFS score of 6 for more than 1 spontaneous bowel movement (SBM) or a BSFS score of 7 for any SBM during the last 7 days of diary reporting for Study SB-2-010-001.
• Subject has any abnormal laboratory results, electrocardiogram (ECG) findings, or physical examination findings deemed clinically significant by the investigator at the Study SB-2-010-001 End-of-Study Visit.

Sponsors & Collaborators

• Theriva Biologics, Inc.: lead

Study Sites (11)

Unknown Facility

Hialeah, Florida, 33012, United States

Location

Unknown Facility

Miami, Florida, 33126, United States

Location

Unknown Facility

Miami, Florida, 33135, United States

Location

Unknown Facility

Miami, Florida, 33165, United States

Location

Unknown Facility

Miami Lakes, Florida, 33014, United States

Location

Unknown Facility

Miami Springs, Florida, 33166, United States

Location

Unknown Facility

St. Petersburg, Florida, 33709, United States

Location

Unknown Facility

Tampa, Florida, 33614, United States

Location

Unknown Facility

Virginia Gardens, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, 33409, United States

Location

Unknown Facility

New York, New York, 10016-8202, United States

Location

Results Point of Contact

• Title: Michael Kaleko
• Organization: Synthetic Biologics Inc

mkaleko@syntheticbiologics.com

(240) 238-3862

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects from the study SB-2-010-001 (NCT02495623) were given either SYN-010 21 mg, SYN-010 42 mg, or Placebo. The subjects were offered the opportunity to roll over into SB-2-010-002 and receive SYN-010 42 mg. Some of the analyses were done from day one of SYN-010-001.

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 9, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 27, 2018
• Results First Posted: March 8, 2017

Record last verified: 2018-10

Locations

US (11)