|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
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 |
| MedlinePlus related topics: | Constipation |
| ChemIDplus related topics: | Linaclotide acetate |
| 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 | |||||
| Ironwood Pharmaceuticals, Inc. |
| Study Director: | Jeffrey M. Johnston, MD, FACP | Microbia, Inc. |
More Information
| Study ID Numbers: | MCP-103-004 |
| First Received: | March 20, 2006 |
| Last Updated: | February 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00306748 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|