Clinical trial NCT00761254: Domperidone for Relief of Gastrointestinal Disorders
Official title: Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
GERD
Esophagitis
Dyspepsia
Chronic Idiopathic Constipation
Nausea
Vomiting
Keywords: Domperidone
Gastroparesis
Lead sponsor: Carle Physician Group
Sponsor class: INDIV
First posted: 2008-09-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Relief for patients with gastrointestinal disorders who have failed standard therapy
timeFrame: As long as the subjects continue to take Domperidone.
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Carle Health Care Incorporated d/b/a Carle Physician Group
state: Illinois
Study officials:
affiliation: Carle Health Care Incorporated d/b/a Carle Physician Group
name: Andrew Batey, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carle Foundation Hospital
name: Anna Keck, PhD
role: STUDY_DIRECTOR
affiliation: Carle Foundation Hospital
name: James Dougherty, MD
role: STUDY_DIRECTOR
affiliation: Carle Physician Group
name: Eugene Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carle Physician Group
name: Vicki Shah, PA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.
citation: Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.
citation: Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003.
citation: Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61.