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Phase I Double-Blind, Placebo-Controlled Trial of 27 mg Dolcanatide (SP-333) to Demonstrate Colorectal Bioactivity in Healthy Volunteers

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.



Schema Description

Healthy potential participants were contacted for an eligibility assessment and an informed consent form. If participants are eligible then they have an initial screen. At this screen participants have a physical exam with vital signs, medical and surgical history, concomitant medications, baseline symptoms, and alcohol and tobacco assessments. They additionally have a blood chemistry and hematology, pregnancy test, and urine drug screen. Next they have a second screen for a sigmoidoscopy after a PEG enema. Once participants pass the initial screens, they are randomized to either take Dolcanatide or a placebo daily for 7 days. At the end of 7 days, participants get an additional physical exam with vitals, repeat blood and urine tests, and an additional sigmoidoscopy after PEG enema. On day 21 +/- 3 days participants get a follow-up additional physical exam with vitals, repeat blood and urine tests, adverse event and concomitant medication assessments, QOL questionnaire, and a final alcohol and tobacco use assessment. At day 51 +/- 3 days, participants get a final follow-up phone call, if needed, to follow unresolved adverse events.