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| Sponsor: | Ironwood Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Ironwood Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00306748 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Drug: MD-1100 Acetate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Multicenter, Double-Blind, Parallel-Design, Phase 2 Trial of Oral MD-1100 Acetate Administered for 14 Days Once Daily at 100 ug, 300 ug, 1000 ug, or Placebo to Patients With Chronic Constipation |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | August 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Clinical Research Associates | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arkansas | |
| Arkansas Gastroenterology | |
| North Little Rock, Arkansas, United States, 72117 | |
| United States, Florida | |
| Consultants for Clinical Research of South Florida | |
| Boynton Beach, Florida, United States, 33426 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Chung H. Kim, MD | |
| Pittsford, New York, United States, 14534 | |
| United States, North Carolina | |
| Vital Research | |
| Greensboro, North Carolina, United States, 27408 | |
| UC for Functional GI & Motility Disorders | |
| Chapel Hill, North Carolina, United States, 27599-7080 | |
| United States, Oklahoma | |
| Sooner Clinical Research | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Tennessee | |
| ClinSearch | |
| Chattanooga, Tennessee, United States, 37304 | |
| Memphis Gastroenterology Clinic | |
| Germantown, Tennessee, United States, 38120 | |
| United States, Texas | |
| Austin Gastroenterology, P.A. | |
| Austin, Texas, United States, 78745 | |
| Trinity Clinic - Corsicana | |
| Corsicana, Texas, United States, 75110 | |
| United States, Virginia | |
| East Coast Clinical Research, LLC | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Vantage Clinical Research | |
| Olympia, Washington, United States, 98506 | |
| Study Director: | Jeffrey M. Johnston, MD, FACP | Microbia, Inc. |
More Information
| Study ID Numbers: | MCP-103-004 |
| Study First Received: | March 20, 2006 |
| Last Updated: | March 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00306748 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Constipation Chronic Idiopathic Constipation Constipation CIC CC MD-1100 |
MD-1100 Acetate Microbia Microbia, Inc. linaclotide linaclotide acetate |
|
Signs and Symptoms Signs and Symptoms, Digestive Constipation |