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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Miami, Florida, United States
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
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Unnamed facility
Miami Lakes, Florida, United States
Unnamed facility
Miami Springs, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Virginia Gardens, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
...and 1 more locations