Oncology Patients With GastroparesisNCT02494687
Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
A study testing Oral Domperidone in people with Oncology Patients With Gastroparesis, run by Eastern Regional Medical Center at 1 site in United States.
Trial summary
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology Patients With Gastroparesis
- What is being tested?
- Oral Domperidone
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 and older
- Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation refractory to standard therapy.
- Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) to eliminate other causes of their symptoms.
- Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
- increased prolactin levels
Show all 9Show fewer
- extrapyramidal side-effects
- breast changes
- cardiac arrhythmias including QT prolongation and death
Who cannot join
- History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
- Clinically significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feeding female
- Known allergy to domperidone
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, 19124
Raman Battish, MD, 215-537-7400, Raman.Battish@ctca-hope.com
Jack Medendorp, 215-537-3160, Jack.Medendorp@ctca-hope.com
About this study
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
Read the detailed description
At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID (four times a day). The Investigator will be starting patients on 10 mg four times a day for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be evaluated at each time point. If the participant still is not having relief of symptoms the investigator may increase their dose to 30mg four times a day.
- Conditions
- Oncology Patients With Gastroparesis
- Being tested
- Oral Domperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral DomperidoneDrug
10 mg of oral domperidone administered (four times a day) for two weeks
Oral DomperidoneDrug
Increased to 20 mg four times a day for 2 weeks at the Investigator's discretion
Oral DomperidoneDrug
Increased to 30 mg four times a day at the Investigator's discretion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology Patients With 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494687
- Sponsor's protocol ID
- EP2014022
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2015
- Last updated
- 10 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT02494687
- Acronym / sponsor ID
- EP2014022
- Conditions
- Oncology Patients With Gastroparesis
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- First posted
- 10 Jul 2015 (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.
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
Detailed description
At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID (four times a day). The Investigator will be starting patients on 10 mg four times a day for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be evaluated at each time point. If the participant still is not having relief of symptoms the investigator may increase their dose to 30mg four times a day.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Age 18 and older
- Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation refractory to standard therapy.
- Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) to eliminate other causes of their symptoms.
- Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
Key exclusion criteria (7 listed)
- History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
- Clinically significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
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 |
|---|---|---|
| Oral Domperidone10 mg of oral domperidone administered (four times a day) for two weeks | Drug | – |
| Oral DomperidoneIncreased to 20 mg four times a day for 2 weeks at the Investigator's discretion | Drug | – |
| Oral DomperidoneIncreased to 30 mg four times a day at the Investigator's discretion | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Domperidone in people with Oncology Patients With Gastroparesis, run by Eastern Regional Medical Center 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raman Battish, MD (215-537-7400, Raman.Battish@ctca-hope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 Mar 2020.