Clincosm LogoSign in Get a demo

Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

Sponsor
Mt. Sinai Medical Center, Miami (Other)
Overall Status
Completed
CT.gov ID
NCT01844622
Collaborator
(none)
37
Enrollment
2
Locations
1
Arm
86.6
Duration (Months)
18.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Domperidone
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
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
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Feb 19, 2015
Actual Study Completion Date :
Feb 19, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying [5 years]

      GERD or Delayed Gastric Emptying

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Division of Gastroenterology, Mt. Sinai Medical Center Miami Beach Florida United States 33140
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None 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
    Other Study ID Numbers:
    • 07-39-H-08
    First Posted:
    May 1, 2013
    Last Update Posted:
    May 16, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by 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
    Digestive System Diseases Disease
    Additional relevant MeSH terms:
    Digestive System Diseases
    Gastrointestinal Diseases
    Domperidone

    Study Results

    No Results Posted as of May 16, 2017