Domperidone for Relief of Gastrointestinal Disorders

This study has been terminated.
(PI withdrew due to increased responsibilities in clinical department.)
Sponsor:
Information provided by (Responsible Party):
Carle Physician Group
ClinicalTrials.gov Identifier:
NCT00761254
First received: September 25, 2008
Last updated: September 11, 2012
Last verified: September 2012

September 25, 2008
September 11, 2012
August 2008
September 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00761254 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Domperidone for Relief of Gastrointestinal Disorders
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroparesis
  • GERD
  • Esophagitis
  • Dyspepsia
  • Chronic Idiopathic Constipation
  • Nausea
  • Vomiting
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy
  • subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.

Exclusion Criteria:

  • history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
  • clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.)
  • clinically significant electrolyte disorders.
  • gastrointestinal hemorrhage or obstruction.
  • presence of a prolactinoma (prolactin-releasing pituitary tumor.)
  • pregnant or breast feeding female.
  • known allergy to Domperidone.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00761254
08-153
No
Carle Physician Group
Carle Physician Group
Not Provided
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
Carle Physician Group
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP