Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying
Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying
Sponsors
Source
Mt. Sinai Medical Center, Miami
Oversight Info
Has Dmc
Yes
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
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
Overall Status
Completed
Start Date
2007-12-01
Completion Date
2015-02-19
Primary Completion Date
2015-02-19
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying |
5 years |
Enrollment
37
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Domperidone
Other Name
Motilium
Motillium
Eligibility
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.
Gender
All
Minimum Age
12 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Jamie S. Barkin, M.D. |
Principal Investigator |
Mt. Sinai Medical Center |
Location
Facility |
|
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 |
Location Countries
Country
United States
Verification Date
2017-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Mt. Sinai Medical Center, Miami
Investigator Full Name
Jamie S. Barkin, M.D.
Investigator Title
Professor of Medicine, U of Miami and Chief, Div of GI, Mt. Sinai Med. Ctr
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Domperidone
Arm Group
Arm Group Label
Domperidone
Arm Group Type
Other
Description
Domperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Study First Submitted
April 29, 2013
Study First Submitted Qc
April 30, 2013
Study First Posted
May 1, 2013
Last Update Submitted
May 15, 2017
Last Update Submitted Qc
May 15, 2017
Last Update Posted
May 16, 2017
ClinicalTrials.gov processed this data on August 29, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.