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Domperidone in Refractory Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00760461
Recruitment Status : Terminated (Enrolled subjects were unable to receive drug from dispensing pharmacy.)
First Posted : September 26, 2008
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Domperidone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Domperidone in Refractory Gastroparesis
Study Start Date : October 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arms and Interventions
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Arm Intervention/treatment
Domperidone Drug: Domperidone
10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily


Outcome Measures
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Primary Outcome Measures :
  1. Gastroparesis Cardinal Symptom Index [ Time Frame: upon study completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Age 18 and older
  • Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
  • Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.

  • Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

    • Increased prolactin levels
    • Breast changes
    • Extrapyramidal side effects
    • Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

  • History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients 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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
  • Gastrointestinal hemorrhage or obstruction.
  • Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  • Pregnant or breast feedings female.
  • Known allergy to domperidone
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760461


Locations
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United States, Connecticut
Yale Digestive Diseases 40 Temple St, Suite 1A
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Anish A Sheth, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00760461    
Other Study ID Numbers: 0809004202
First Posted: September 26, 2008    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Domperidone
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action