Domperidone for Relief of Gastrointestinal Disorders

This study has been terminated.
(PI withdrew due to increased responsibilities in clinical department.)
Sponsor:
Information provided by (Responsible Party):
Carle Physician Group
ClinicalTrials.gov Identifier:
NCT00761254
First received: September 25, 2008
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Gastroparesis
GERD
Esophagitis
Dyspepsia
Chronic Idiopathic Constipation
Nausea
Vomiting
Drug: Domperidone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy

Resource links provided by NLM:


Further study details as provided by Carle Physician Group:

Primary Outcome Measures:
  • Relief for patients with gastrointestinal disorders who have failed standard therapy [ Time Frame: As long as the subjects continue to take Domperidone. ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: August 2008
Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Domperidone
    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.
    Other Name: Motilium
Detailed Description:

Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.

According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.

This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.
  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: NCT00761254

Locations
United States, Illinois
Carle Health Care Incorporated d/b/a Carle Physician Group
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
Carle Physician Group
Investigators
Principal Investigator: Andrew Batey, M.D. Carle Health Care Incorporated d/b/a Carle Physician Group
Study Director: Anna Keck, PhD Carle Foundation Hospital
Study Director: James Dougherty, MD Carle Foundation Hospital
Principal Investigator: Eugene Greenberg, MD Carle Physician Group
Principal Investigator: Vicki Shah, PA Carle Physician Group
  More Information

Publications:
Responsible Party: Carle Physician Group
ClinicalTrials.gov Identifier: NCT00761254     History of Changes
Other Study ID Numbers: 08-153
Study First Received: September 25, 2008
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Carle Physician Group:
Domperidone
Gastroparesis

Additional relevant MeSH terms:
Constipation
Dyspepsia
Esophagitis
Digestive System Diseases
Gastrointestinal Diseases
Nausea
Vomiting
Gastroparesis
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Diseases
Gastroenteritis
Stomach Diseases
Paralysis
Neurologic Manifestations
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 August 18, 2014