Domperidone for Relief of Gastrointestinal Disorders

Nausea Clinical Trial

Official title:

Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00761254
• Other study ID #: 08-153
• Status: Terminated
• Phase: N/A
• First received: September 25, 2008
• Last updated: September 11, 2012
• Start date: August 2008
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Carle Physician Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation
• Digestive System Diseases
• Dyspepsia
• Esophagitis
• Gastrointestinal Diseases
• Gastroparesis
• GERD
• Nausea
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
United States	Carle Health Care Incorporated d/b/a Carle Physician Group	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Carle Physician Group

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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

Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61. Review. — View 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. Epub 2007 May 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief for patients with gastrointestinal disorders who have failed standard therapy		As long as the subjects continue to take Domperidone.	No