Back to resultsA Study of the Effect of SYN-010 on Subjects With IBS-C
Primary Purpose
Irritable Bowel Syndrome With Constipation (IBS-C)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SYN-010 21 mg
SYN-010 42 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation (IBS-C)
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Low Dose
High Dose
Placebo
Arm Description
21 mg SYN-010
42 mg SYN-010
Placebo
Outcomes
Primary Outcome Measures
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
Secondary Outcome Measures
Full Information
NCT ID
NCT02495623
First Posted
June 29, 2015
Last Updated
October 31, 2018
Sponsor
Theriva Biologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02495623
Brief Title
A Study of the Effect of SYN-010 on Subjects With IBS-C
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theriva Biologics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation (IBS-C)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose
Arm Type
Active Comparator
Arm Description
21 mg SYN-010
Arm Title
High Dose
Arm Type
Active Comparator
Arm Description
42 mg SYN-010
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SYN-010 21 mg
Intervention Type
Drug
Intervention Name(s)
SYN-010 42 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kaleko, M.D.
Organizational Affiliation
Synthetic Biologics
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of SYN-010 on Subjects With IBS-C
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