The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acetate administered daily for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Clinical Research Associates
Huntsville, Alabama, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Consultants for Clinical Research of South Florida
Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
Stool Frequency will be reported daily
Stool Consistency (Bristol Stool Form Scale) will be reported daily
Stool Ease of Passage will be reported daily
Stool Completeness of Evacuation will be reported daily
Patient Assessment of Abdominal Discomfort will be reported weekly
Patient Assessment of Constipation will be reported weekly
Patient Assessment of Overall Relief will be reported weekly
Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.
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Boynton Beach, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Chung H. Kim, MD
Pittsford, New York, United States
UC for Functional GI & Motility Disorders
Chapel Hill, North Carolina, United States
Vital Research
Greensboro, North Carolina, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
ClinSearch
Chattanooga, Tennessee, United States
Memphis Gastroenterology Clinic
Germantown, Tennessee, United States
...and 4 more locations