Domperidone in Refractory Gastroparesis

This study has suspended participant recruitment.
(Subjects currently unable to receive drug from dispensing pharmacy.)
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00760461
First received: September 24, 2008
Last updated: March 28, 2011
Last verified: March 2011
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 2011
Estimated Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760461

Locations
United States, Connecticut
Yale Digestive Diseases 40 Temple St, Suite 1A
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Anish A Sheth, MD Yale University
  More Information

No publications provided

Responsible Party: Anish A Sheth M.D., Yale University
ClinicalTrials.gov Identifier: NCT00760461     History of Changes
Other Study ID Numbers: 0809004202
Study First Received: September 24, 2008
Last Updated: March 28, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014