Digestive System DiseaseNCT01844622
Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying
A study testing Domperidone in people with Digestive System Disease, run by Mt. Sinai Medical Center, Miami at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Digestive System Disease
- What is being tested?
- Domperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to 19 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent esophagitis
- Heartburn
- Nausea
- Vomiting
- Severe dyspepsia
- Severe chronic constipation
Who cannot join
- History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Gastroenterology, Mt. Sinai Medical Center
Miami Beach, Florida, 33140
Mt. Sinai Medical Center, Division of Gastroenterology
Miami Beach, Florida, 33140
About this study
Official title: Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying
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
- Conditions
- Digestive System Disease
- Being tested
- Domperidone
- Keywords
- Digestive System Diseases Disease
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneOther
Also called Motilium, Motillium
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying
GERD or Delayed Gastric Emptying
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startDec 2007
- Primary completion19 Feb 2015
- Study completion19 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie S. Barkin, M.D., Mt. Sinai Medical Center, Miami
- Investigators
- Jamie S. Barkin, M.D., Principal investigator, Mt. Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844622
- Sponsor's protocol ID
- 07-39-H-08
- Status last verified
- May 2017
- First submitted
- 29 Apr 2013
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying
- ClinicalTrials.gov ID
- NCT01844622
- Acronym / sponsor ID
- 07-39-H-08
- Conditions
- Digestive System Disease
- Keywords
- Digestive System Diseases Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- 19 Feb 2015 (actual)
- Study completion
- 19 Feb 2015 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Domperidone | Other | Other: DomperidoneDomperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Persistent esophagitis
- Heartburn
- Nausea
- Vomiting
- Severe dyspepsia
Key exclusion criteria (1 listed)
- History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomperidoneAlso: Motilium, MotilliumDomperidone 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 | Domperidone |
Primary outcome
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying
Time frame: 5 years
GERD or Delayed Gastric Emptying
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Related trials for Digestive System Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie S. Barkin, M.D. principal investigator
Mt. Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domperidone in people with Digestive System Disease, run by Mt. Sinai Medical Center, Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.