NCT01844622

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2015

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

7.2 years

First QC Date

April 29, 2013

Last Update Submit

May 15, 2017

Conditions

Digestive System Disease

Keywords

Digestive System Diseases Disease

Outcome Measures

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

    5 years

Study Arms (1)

Domperidone

OTHER

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

DomperidoneOTHER

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
Domperidone

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Gastroenterology, Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Mt. Sinai Medical Center, Division of Gastroenterology

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Domperidone

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jamie S. Barkin, M.D.

    Mt. Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, U of Miami and Chief, Div of GI, Mt. Sinai Med. Ctr

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

December 1, 2007

Primary Completion

February 19, 2015

Study Completion

February 19, 2015

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

US(2)