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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD-1100 Acetate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting. |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Frequency will be reported daily | ||
| Stool Consistency (Bristol Stool Form Scale) will be reported daily | ||
| Stool Ease of Passage will be reported daily |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M. Johnston, MD, FACP | Microbia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Associates | Huntsville | Alabama | 35801 | United States | ||
| Arkansas Gastroenterology |
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| 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. |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Consultants for Clinical Research of South Florida | Boynton Beach | Florida | 33426 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Chung H. Kim, MD | Pittsford | New York | 14534 | United States |
| UC for Functional GI & Motility Disorders | Chapel Hill | North Carolina | 27599-7080 | United States |
| Vital Research | Greensboro | North Carolina | 27408 | United States |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| ClinSearch | Chattanooga | Tennessee | 37304 | United States |
| Memphis Gastroenterology Clinic | Germantown | Tennessee | 38120 | United States |
| Austin Gastroenterology, P.A. | Austin | Texas | 78745 | United States |
| Trinity Clinic - Corsicana | Corsicana | Texas | 75110 | United States |
| East Coast Clinical Research, LLC | Virginia Beach | Virginia | 23454 | United States |
| Vantage Clinical Research | Olympia | Washington | 98506 | United States |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C523483 | linaclotide |
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