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Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying (No)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Mt. Sinai Medical Center, Miami
Sponsor:
Information provided by (Responsible Party):
Jamie S. Barkin, M.D., Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT01844622
First received: April 29, 2013
Last updated: May 8, 2013
Last verified: May 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    GERD or Delayed Gastric Emptying


Estimated Enrollment: 500
Study Start Date: December 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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: NCT01844622

Contacts
Contact: Jamie S Barkin, M.D. 305-674-2240 jamiebarkin@msmc.com

Locations
United States, Florida
Division of Gastroenterology, Mt. Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jamie S Barkin, M.D.    305-674-2240    jamiebarkin@msmc.com   
Principal Investigator: Jamie S. Barkin, M.D         
Mt. Sinai Medical Center, Division of Gastroenterology Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jamie S Barkin, M.D.    305-674-2240    jamiebarkin@msmc.com   
Principal Investigator: Jamie S Barkin, M.D.         
Mt. Sinai Medical Center, Division of Gastroenterology Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jamie S. Barkin, M.D.    305-674-2240    jamiebarkin@msmc.com   
Principal Investigator: Jamie S Barkin, M.D.         
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Investigators
Principal Investigator: Jamie S. Barkin, M.D. Mt. Sinai Medical Center
  More Information

No publications provided

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
Study First Received: April 29, 2013
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mt. Sinai Medical Center, Miami:
Digestive System Diseases Disease

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Gastroesophageal Reflux
Deglutition Disorders
Esophageal Diseases
Esophageal Motility Disorders
Domperidone
Antiemetics
Autonomic Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014