NCT00761254

Domperidone for Relief of Gastrointestinal Disorders

Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Carle Physician Group · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastroparesis
• GERD
• Esophagitis
• Dyspepsia
• Chronic Idiopathic Constipation
• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Domperidone	Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2008-09-29
• Last updated: 2012-09-13

Locations

1 site across 1 country: United States