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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.
ClinicalTrials.gov Identifier:
NCT02495623
First received: June 29, 2015
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
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)

Condition Intervention Phase
Irritable Bowel Syndrome With Constipation (IBS-C) Drug: SYN-010 21 mg Drug: SYN-010 42 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Synthetic Biologics Inc.:

Primary Outcome Measures:
  • Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 [ Time Frame: 7 days ]

Enrollment: 63
Study Start Date: June 2015
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose
21 mg SYN-010
Drug: SYN-010 21 mg
Active Comparator: High Dose
42 mg SYN-010
Drug: SYN-010 42 mg
Placebo Comparator: Placebo
Placebo
Drug: Placebo

Detailed 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).
  Eligibility

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

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).
  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: NCT02495623

Locations
United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
Synthetic Biologics Inc.
Investigators
Study Director: Klaus Gottlieb, M.D. Synthetic Biologics
  More Information

Responsible Party: Synthetic Biologics Inc.
ClinicalTrials.gov Identifier: NCT02495623     History of Changes
Other Study ID Numbers: SB-2-010-001
Study First Received: June 29, 2015
Results First Received: January 18, 2017
Last Updated: June 26, 2017

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
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 July 26, 2017