Domperidone for Relief of Gastrointestinal Disorders

NCT00761254 | Terminated

• 1 other identifier: 08-153
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis; GERD; Esophagitis; Dyspepsia; Chronic Idiopathic Constipation; Nausea; Vomiting

Keywords

Domperidone; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Relief for patients with gastrointestinal disorders who have failed standard therapy

  As long as the subjects continue to take Domperidone.

Interventions

Domperidone DRUG

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.

Also known as: Motilium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carle Physician Group: lead

Study Sites (1)

Carle Health Care Incorporated d/b/a Carle Physician Group

Urbana, Illinois, 61801, United States

Location

Related 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. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.

  PMID: 16997628 BACKGROUND

• 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.

  PMID: 17488253 BACKGROUND

• Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003.

  PMID: 10332535 BACKGROUND

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

  PMID: 3527396 BACKGROUND

MeSH Terms

Conditions

Gastroparesis; Gastroesophageal Reflux; Esophagitis; Dyspepsia; Nausea; Vomiting

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroenteritis; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew Batey, M.D.

  Carle Health Care Incorporated d/b/a Carle Physician Group

  PRINCIPAL INVESTIGATOR

• Anna Keck, PhD

  Carle Foundation Hospital

  STUDY DIRECTOR

• James Dougherty, MD

  Carle Foundation Hospital

  STUDY DIRECTOR

• Eugene Greenberg, MD

  Carle Physician Group

  PRINCIPAL INVESTIGATOR

• Vicki Shah, PA

  Carle Physician Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

US (1)