Domperidone for Relief of Gastrointestinal Disorders
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.
Chronic Idiopathic Constipation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy|
- Relief for patients with gastrointestinal disorders who have failed standard therapy [ Time Frame: As long as the subjects continue to take Domperidone. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.
According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.
This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.
|United States, Illinois|
|Carle Health Care Incorporated d/b/a Carle Physician Group|
|Urbana, Illinois, United States, 61801|
|Principal Investigator:||Andrew Batey, M.D.||Carle Health Care Incorporated d/b/a Carle Physician Group|
|Study Director:||Anna Keck, PhD||Carle Foundation Hospital|
|Study Director:||James Dougherty, MD||Carle Foundation Hospital|
|Principal Investigator:||Eugene Greenberg, MD||Carle Physician Group|
|Principal Investigator:||Vicki Shah, PA||Carle Physician Group|