Recruiting

Domperidone

Sponsor:

Arnold, George, M.D.

Code:

NCT00777439

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Domperidone

Study Details

Brief summary:

The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Conditions

Gastroparesis

Study ID

NCT00777439

Start date

Oct, 2008

Status verified date

Aug, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female
  • Age 18 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 are refractory to standard therapy.
  • Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
  • Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:

  • increased prolactin levels
  • extrapyramidal side effects
  • breast changes
  • cardiac arrhythmias including QT prolongation
  • there is a potential for increased risk of adverse events with the drugs listed in the addendum

Exclusion Criteria:

  • History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
  • 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 QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
  • Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  • Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
  • Pregnant or breast feeding female.
  • Known allergy to domperidone or any components of the domperidone formulation.
  • Significantly significant electrolyte disorders.
  • Gastrointestinal hemorrhage or obstruction.

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Domperidone

All eligible subjects will receive domperidone in an open label, single group assignment.

Interventions

Domperidone

10 mg of oral domperidone will be administered 4 times daily. This dose may be increased to 20 mg 4 times daily or 30 mg 4 times daily, depending on how the subject responds to the drug.

Primary outcome measure

  • Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment. [ Time Frame: Domperidone will be prescrided as long as patients benefit from taking it. ]

Central Contacts and Locations

Central contacts

Kelly A Kolesar, BSN

412-864-7087kolesarka2@upmc.edu

George L. Arnold, MD

412-864-7087arnoldgl@upmc.edu

Locations

Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kelly A. Kolesar, BSN

412-864-7087kolesarka2@upmc.edu

Principal Investigator:

George L. Arnold, MD

More Information

Sponsor

Arnold, George, M.D.

Last update posted

Aug 18, 2016

Last verified

Aug, 2016

Keywords

  • Dopamine
  • Domperidone
  • Gastroparesis
  • Gastrointestinal Diseases
  • Neurologic Manifestations
  • Stomach Diseases
  • Digestive System Diseases
  • Esophagitis
  • Esophageal Disorders
  • Paralysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arnold, George, M.D. on 2016-08-18.