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Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844622
First Posted: May 1, 2013
Last Update Posted: May 16, 2017
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.
Information provided by (Responsible Party):
Jamie S. Barkin, M.D., Mt. Sinai Medical Center, Miami
  Purpose
The purpose of the study is to treat patients with on-going slow stomach emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy

Condition Intervention
Digestive System Disease Other: Domperidone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying

Resource links provided by NLM:


Further study details as provided by Jamie S. Barkin, M.D., Mt. Sinai Medical Center, Miami:

Primary Outcome Measures:
  • Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying [ Time Frame: 5 years ]
    GERD or Delayed Gastric Emptying


Enrollment: 37
Study Start Date: December 2007
Study Completion Date: February 19, 2015
Primary Completion Date: February 19, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Domperidone
Domperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy
Other: Domperidone
Domperidone dosage may be increased depending on how well the patient responds. However before increasing the dosage, patients will have follow-up EKG to evaluate any possible side effects including irregular heartbeats.
Other Names:
  • Motilium
  • Motillium

Detailed Description:
This is a study on the effectiveness of domperidone, which increases movement through the digestive system for relief of symptoms, in patients who have delayed gastric solid-phase emptying
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent esophagitis
  • Heartburn
  • Nausea
  • Vomiting
  • Severe dyspepsia
  • Severe chronic constipation

Exclusion Criteria:

  • History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.
  Contacts and Locations
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): NCT01844622


Locations
United States, Florida
Division of Gastroenterology, Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140
Mt. Sinai Medical Center, Division of Gastroenterology
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Investigators
Principal Investigator: Jamie S. Barkin, M.D. Mt. Sinai Medical Center
  More Information

Responsible Party: Jamie S. Barkin, M.D., Professor of Medicine, U of Miami and Chief, Div of GI, Mt. Sinai Med. Ctr, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT01844622     History of Changes
Other Study ID Numbers: 07-39-H-08
First Submitted: April 29, 2013
First Posted: May 1, 2013
Last Update Posted: May 16, 2017
Last Verified: May 2017

Keywords provided by Jamie S. Barkin, M.D., Mt. Sinai Medical Center, Miami:
Digestive System Diseases Disease

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
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