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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.
ClinicalTrials.gov Identifier:
NCT02493036
First received: June 29, 2015
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
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

Condition Intervention Phase
Irritable Bowel Syndrome With Constipation (IBS-C) Drug: SYN-010 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Synthetic Biologics Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 56 days ]

Enrollment: 54
Study Start Date: October 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose SYN-010
42-mg SYN-010
Drug: SYN-010

Detailed Description:
This is a Phase 2, multi-center, open-label study. Up to sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. Subjects must have completed the previous SB-2-010-001 study. The entire duration of the study may be up to 57 days (from enrollment to the post end-of-study [EOS] visit telephone call).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02493036

Locations
United States, Florida
Hialeah, Florida, United States, 33012
Miami Lakes, Florida, United States, 33014
Miami Springs, Florida, United States, 33166
Miami, Florida, United States, 33126
Miami, Florida, United States, 33135
Miami, Florida, United States, 33165
Saint Petersburg, Florida, United States, 33709
Tampa, Florida, United States, 33614
Virginia Gardens, Florida, United States
West Palm Beach, Florida, United States, 33409
United States, New York
New York, New York, United States, 10016-8202
Sponsors and Collaborators
Synthetic Biologics Inc.
  More Information

Responsible Party: Synthetic Biologics Inc.
ClinicalTrials.gov Identifier: NCT02493036     History of Changes
Other Study ID Numbers: SB-2-010-002
Study First Received: June 29, 2015
Results First Received: January 18, 2017
Last Updated: June 26, 2017

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 19, 2017