Domperidone for Relief of Gastrointestinal Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00761254|
Recruitment Status : Terminated (PI withdrew due to increased responsibilities in clinical department.)
First Posted : September 29, 2008
Last Update Posted : September 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis GERD Esophagitis Dyspepsia Chronic Idiopathic Constipation Nausea Vomiting||Drug: Domperidone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- 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.Other Name: Motilium
- Relief for patients with gastrointestinal disorders who have failed standard therapy [ Time Frame: As long as the subjects continue to take Domperidone. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761254
|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|