Domperidone for Relief of Gastrointestinal Disorders
| Status: | Archived |
|---|---|
| Conditions: | Constipation, Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2008 |
| End Date: | January 2013 |
Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
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.
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.
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