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CompletedNCT01844622Updated May 16, 2017

Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

An interventional study of Domperidone in Digestive System Disease, sponsored by Mt. Sinai Medical Center, Miami. Completed at 2 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-05-16.

Sponsored by Mt. Sinai Medical Center, Miami · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Digestive System Disease

Keywords

  • Digestive System Diseases Disease
03

In context

Digestive System Diseases

613 studies on the registry are indexed under Digestive System Diseases; 117 are open to participants now.

This study's enrollment of 37 is below the median of 80 across 401 interventional studies indexed under Digestive System Diseases.

Browse Digestive System Diseases studies →

Lead sponsor

Mt. Sinai Medical Center, Miami is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • 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

Interventions

  • OtherDomperidone

    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.

    Also known as: Motilium, Motillium

06

What researchers measure

Primary outcomes

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

    GERD or Delayed Gastric Emptying

    Time frame: 5 years

07

Study locations

2 sites
  • Division of Gastroenterology, Mt. Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Mt. Sinai Medical Center, Division of Gastroenterology
    Miami Beach, Florida 33140, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01844622
Lead sponsor
Mt. Sinai Medical Center, Miami
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) — Principal investigator
First posted
May 1, 2013
Start date
Dec 2007
Primary completion
Feb 19, 2015
Completion
Feb 19, 2015
Last update
May 16, 2017

Study contacts

Jamie S. Barkin, M.D.
principal investigator · Mt. Sinai Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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