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

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ClinicalTrials.gov Identifier: NCT02495623
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : March 8, 2017
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.

Tracking Information
First Submitted Date  ICMJE June 29, 2015
First Posted Date  ICMJE July 13, 2015
Results First Submitted Date  ICMJE January 18, 2017
Results First Posted Date  ICMJE March 8, 2017
Last Update Posted Date November 27, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2015)
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT02495623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effect of SYN-010 on Subjects With IBS-C
Official Title  ICMJE 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
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)
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome With Constipation (IBS-C)
Intervention  ICMJE
  • Drug: SYN-010 21 mg
  • Drug: SYN-010 42 mg
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Low Dose
    21 mg SYN-010
    Intervention: Drug: SYN-010 21 mg
  • Active Comparator: High Dose
    42 mg SYN-010
    Intervention: Drug: SYN-010 42 mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2015)
63
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2015)
60
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02495623
Other Study ID Numbers  ICMJE SB-2-010-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Synthetic Biologics Inc.
Study Sponsor  ICMJE Synthetic Biologics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Kaleko, M.D. Synthetic Biologics
PRS Account Synthetic Biologics Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP