Domperidone for Relief of Gastrointestinal Disorders - Full Text View

Sponsor:	Greenberg, Eugene, M.D.
Information provided by:	Greenberg, Eugene, M.D.
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	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:

Drug Information available for: Domperidone Domperidone maleate

U.S. FDA Resources

Further study details as provided by Greenberg, Eugene, M.D.:

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:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	August 2010 (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.

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 des 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

Contacts

Contact: Micki J Suits, RN	217-326-0058	micki.suits@carle.com
Contact: Eugene Greenberg, MD	217-326-0058	eugene.greenberg@carle.com

Locations

United States, Illinois
Carle Clinic Association	Recruiting
Urbana, Illinois, United States, 61801
Contact: Micki Suits, RN 217-326-0058 micki.suits@carle.com
Contact: Pat Hanson, Administrative Secretary 217-326-0058 patricia.hanson@carle.com
Principal Investigator: Eugene Greenberg, MD
Sub-Investigator: Thomas de Torres, PA-C
Sub-Investigator: Andrew Batey, MD
Sub-Investigator: Gary Griglione, MD
Sub-Investigator: Jeffrey Hallett, MD
Sub-Investigator: Thomas Huber, MD

Sponsors and Collaborators

Greenberg, Eugene, M.D.

Investigators

Principal Investigator:

Eugene Greenberg, MD

Carle Clinic Association

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 Clinic Association ( Eugene Greenberg, M.D. )
Study ID Numbers:	08-153
Study First Received:	September 25, 2008
Last Updated:	February 26, 2010
ClinicalTrials.gov Identifier:	NCT00761254 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Greenberg, Eugene, M.D.:

Domperidone
Gastroparesis

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists
Pharmacologic Actions
Paralysis
Esophagitis
Signs and Symptoms
Digestive System Diseases

Stomach Diseases
Domperidone
Autonomic Agents
Therapeutic Uses
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Esophageal Diseases
Gastroenteritis
Central Nervous System Agents
Gastroparesis

ClinicalTrials.gov processed this record on March 18, 2010