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Domperidone in Refractory Gastroparesis
This study is currently recruiting participants.
Verified by Yale University, February 2009
First Received: September 24, 2008   Last Updated: February 2, 2009   History of Changes
Sponsor: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00760461
  Purpose

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 Intervention Phase
Gastroparesis
Drug: Domperidone
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Domperidone in Refractory Gastroparesis

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improvement in Gastroparesis Cardinal Symptom Index [ Time Frame: upon study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Domperidone Drug: Domperidone
10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760461

Contacts
Contact: Christal M Esposito 203-785-4576 christal.esposito@yale.edu

Locations
United States, Connecticut
Yale Digestive Diseases 40 Temple St, Suite 1A Recruiting
New Haven, Connecticut, United States, 06510
Contact: Christal M Esposito     203-785-4576     christal.esposito@yale.edu    
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Anish A Sheth, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University ( Anish A Sheth M.D. )
Study ID Numbers: 0809004202
Study First Received: September 24, 2008
Last Updated: February 2, 2009
ClinicalTrials.gov Identifier: NCT00760461     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists
Pharmacologic Actions
Paralysis
Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Domperidone
Autonomic Agents
Therapeutic Uses
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastroparesis

ClinicalTrials.gov processed this record on February 08, 2010