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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

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ClinicalTrials.gov Identifier: NCT02493036
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : March 8, 2017
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.

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

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

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: High Dose SYN-010
42-mg SYN-010
Drug: SYN-010



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Synthetic Biologics Inc.
ClinicalTrials.gov Identifier: NCT02493036     History of Changes
Other Study ID Numbers: SB-2-010-002
First Posted: July 9, 2015    Key Record Dates
Results First Posted: March 8, 2017
Last Update Posted: November 27, 2018
Last Verified: October 2018

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