Domperidone for Relief of Gastrointestinal Disorders - Full Text View

Sponsor:	Carle Physician Group
Information provided by (Responsible Party):	Carle Physician Group
ClinicalTrials.gov Identifier:	NCT00761254

Purpose

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.

Condition	Intervention
Gastroparesis GERD Esophagitis Dyspepsia Chronic Idiopathic Constipation Nausea Vomiting	Drug: Domperidone

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Constipation Indigestion Nausea and Vomiting

Drug Information available for: Domperidone Domperidone maleate

U.S. FDA Resources

Further study details as provided by Carle Physician Group:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761254

Locations

United States, Illinois
Carle Health Care Incorporated d/b/a Carle Physician Group
Urbana, Illinois, United States, 61801

Sponsors and Collaborators

Carle Physician Group

Investigators

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:	Charles Sanders, MD	Carle Foundation Hospital
Principal Investigator:	Eugene Greenberg, MD	Carle Physician Group
Principal Investigator:	Vicki Shah, PA	Carle Physician Group

More Information

Publications:

Ahmad N, Keith-Ferris J, Gooden E, Abell T. Making a case for domperidone in the treatment of gastrointestinal motility disorders. Curr Opin Pharmacol. 2006 Dec;6(6):571-6. Epub 2006 Sep 25. Review.

Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. Epub 2007 May 3. Review.

Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. Review.

Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61. Review.

Responsible Party:	Carle Physician Group
ClinicalTrials.gov Identifier:	NCT00761254 History of Changes
Other Study ID Numbers:	08-153
Study First Received:	September 25, 2008
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Carle Physician Group:

Domperidone
Gastroparesis

Additional relevant MeSH terms:

Constipation
Dyspepsia
Esophagitis
Gastrointestinal Diseases
Nausea
Vomiting
Gastroparesis
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases
Paralysis

Neurologic Manifestations
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012