GastroparesisNCT00552422
Domperidone for Gastroparesis in Solid Organ Transplantation
A study testing domperidone in people with Gastroparesis and Gastroesophageal Reflux, run by David J. Lederer, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Gastroesophageal Reflux
- What is being tested?
- domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
- signed informed consent
Who cannot join
- serious cardiac arrhythmias
- clinically significant bradycardia, sinus node dysfunction, or heart block.
- prolonged QTc
- clinically significant electrolyte disorders.
- gastrointestinal hemorrhage or obstruction.
- prolactinoma
- pregnant or breast feeding female
- known allergy to domperidone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Domperidone for Gastroparesis Associated With Solid Organ Transplantation
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
Read the detailed description
After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients.
Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth.
We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).
- Conditions
- Gastroparesis, Gastroesophageal Reflux
- Being tested
- domperidone
- Keywords
- gastroparesis, gastroesophageal reflux
- Medical subject headings
- Gastroparesis, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
domperidoneDrug
10mg orally four times per day
| Study group | Role | What they receive |
|---|---|---|
| Domperidone Arm | Experimental | Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day. Receives: Drug: domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Improvement
The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Lack of perceived need for domperidone in this population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- David J. Lederer, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David J. Lederer, M.D., Columbia University
- Investigators
- David J Lederer, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552422
- Sponsor's protocol ID
- AAAC3728
- Status last verified
- Jun 2015
- First submitted
- 31 Oct 2007
- Last updated
- 10 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domperidone for Gastroparesis Associated With Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT00552422
- Acronym / sponsor ID
- AAAC3728
- Conditions
- Gastroparesis, Gastroesophageal Reflux
- Keywords
- gastroparesis, gastroesophageal reflux
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of perceived need for domperidone in this population
- Enrolment
- 6 participants (actual)
- Lead sponsor
- David J. Lederer, M.D.University, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 10 Jul 2015
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 this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
Detailed description
After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients.
Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth.
We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Domperidone Arm | Experimental | Drug: domperidoneStudy subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
- signed informed consent
Key exclusion criteria (8 listed)
- serious cardiac arrhythmias
- clinically significant bradycardia, sinus node dysfunction, or heart block.
- prolonged QTc
- clinically significant electrolyte disorders.
- gastrointestinal hemorrhage or obstruction.
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 |
|---|---|---|
| domperidone10mg orally four times per day | Drug | Domperidone Arm |
Primary outcome
Symptomatic Improvement
Time frame: 2 months
The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David J Lederer, M.D. principal investigator
Columbia University
1 site 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 Gastroparesis and Gastroesophageal Reflux, run by David J. Lederer, M.D. at 1 site 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 10 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptomatic Improvement (time frame: 2 months). 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 10 Jul 2015.