Phase 2
N=79
A Study of the Effect of SYN-010 on Subjects With IBS-C
Irritable Bowel Syndrome With Constipation (IBS-C)
Bottom Line
View on ClinicalTrials.gov: NCT02495623 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 — 99.2; 57.3; 72.7 hours*ppm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SYN-010 21 mg (Drug); SYN-010 42 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theriva Biologics, Inc.
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7 |
99.2; 57.3; 72.7 | — |
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)
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).
Data sourced from ClinicalTrials.gov (NCT02495623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.