Domperidone for Gastroparesis and Acid Reflux
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Mercy Hospital Kansas City
Disqualifiers: Arrhythmias, Bradycardia, Electrolyte disorders, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this program is to allow the use of domperidone in children from 12 to 21 years of age with symptoms related to motility disorders and Gastroesophageal reflux disease (GERD) who have failed all the standard treatments for their condition.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but there is a potential for increased risk with certain drugs and herbal supplements. You should discuss your current medications with the trial coordinator to understand any risks and necessary precautions.
What data supports the effectiveness of the drug domperidone for treating gastroparesis and acid reflux?
Research shows that domperidone has been successfully used for decades to treat gastroparesis, improving symptoms and accelerating gastric emptying. It is also effective in controlling nausea and vomiting, with studies demonstrating its superior efficacy compared to placebo and other treatments.12345
Is domperidone safe for human use?
Domperidone is generally well-tolerated and does not have significant toxic effects, but there have been some concerns about its cardiac safety, although data on this are not convincing. It has been used safely in various conditions, including gastroparesis and postoperative nausea, without hindering other treatments.12346
What makes the drug Domperidone unique for treating gastroparesis and acid reflux?
Research Team
JC
Jose Cocjin, MD
Principal Investigator
Children's Mercy Hospital Kansas City
Eligibility Criteria
This trial is for children and young adults aged 12-21 with severe symptoms of GERD or gastroparesis that haven't improved with standard treatments. They must understand the risks, including heart issues and hormonal changes, and not be pregnant, breastfeeding, or have certain heart conditions or allergies to domperidone.Inclusion Criteria
I am not taking any drugs or supplements listed as risky in the trial's addendum.
I have noticed changes in my breast.
I have side effects from medication that affect my body movements.
See 7 more
Exclusion Criteria
You have important problems with the minerals in your body.
Pregnant or breast feeding female
I have had bleeding or blockage in my digestive tract.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive domperidone 4 times per day, with dose calculated by weight
12 months
6 visits (in-person) every 2 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
1 visit (in-person) every 6 months
Treatment Details
Interventions
- Domperidone (Dopamine Antagonist)
Trial OverviewDomperidone is being used compassionately for those who have not responded to typical therapies for motility disorders like gastroparesis and GERD-related symptoms. The trial aims to provide relief from nausea, vomiting, and other digestive problems.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Overall StudyExperimental Treatment1 Intervention
Receive domperidone 4 times a day, weight-dependent dose
Domperidone is already approved in European Union, Canada, United States for the following indications:
🇪🇺 Approved in European Union as Motilium for:
- Nausea and vomiting
- Gastroparesis
- Gastrointestinal motility disorders
🇨🇦 Approved in Canada as Motilium for:
- Nausea and vomiting
- Gastroparesis
- Gastrointestinal motility disorders
🇺🇸 Approved in United States as Domperidone for:
- Severe and treatment-refractory gastrointestinal motility problems (under expanded access IND)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Mercy Hospitals and ClinicsKansas City, MO
Loading ...
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
Trials
261
Patients Recruited
941,000+
References
The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed-intolerant critically ill patients: a randomized, blinded, placebo-controlled, clinical trial. [2018]The promotility agents currently available to treat gastroparesis and feed intolerance in the critically ill are limited by adverse effects. The aim of this study was to assess the pharmacodynamic effects and pharmacokinetics of single doses of the novel gastric promotility agent motilin agonist camicinal (GSK962040) in critically ill feed-intolerant patients.
Making a case for domperidone in the treatment of gastrointestinal motility disorders. [2013]There are very few treatment options currently available for patients with gastrointestinal motility disorders, especially patients with gastroparesis. Domperidone, a peripheral dopamine receptor antagonist, has been successfully used for decades in the US and marketed in many countries for the treatment of gastroparesis. Its use, however, has recently become controversial owing to safety concerns, and it has never been approved for marketing by the FDA. During the 1990s, domperidone was available to US gastroenterologists under a compassionate-use program by Janssen Pharmaceutica, as the manufacturer worked towards, and fell short of, full US market approval. Medical studies, trials and case reports demonstrate the superior efficacy of domperidone when compared with placebo and other pharmaceutical therapies available. Data on the cardiac toxicity associated with oral use of domperidone fail to be convincing.
Role of domperidone in improving intestinal activity in acute myocardial infarction patients. [2013]Domperidone has been used as a gastrokinetic and anti-emetic drug within the frames of an intensive care programme in 57 patients with a history of 3-4 days of acute myocardial infarction. According to the observations, Motilium prevents the development of gastroduodenal complaints and nausea, vomiting in a period following the first days of acute therapy and promotes the start of bowel movement and defecation. It has no cardiac or other toxic effects and does not influence the action of other drugs.
The importance of domperidone (Motilium) in controlling postoperative nausea and vomiting. [2013]Comparative study was performed for assessing the postoperative anti-emetic and emesis preventive effect of domperidone. It has been found that the emesis preventive effect of Motilium tablet is identical with the effect of the well known Daedalon (Dramamin) and Torecan. From the therapeutic aspect it is of value especially in controlling nausea and in the prevention of subsequent vomiting following the use of rectal anti-emetics. This difference is attributable to the oral route of administration. Considering the lack of toxic effects domperidone is the most favourable.
The effect of chronic oral domperidone therapy on gastrointestinal symptoms, gastric emptying, and quality of life in patients with gastroparesis. [2016]Our aim was to determine whether domperidone could improve the symptoms of patients with gastroparesis, accelerate gastric emptying, and enhance quality of life.
Use of peripheral dopamine antagonist (Motilium) in the treatment of dyspeptic complaints of different origin and in nausea, vomiting. [2013]The incidence of dyspepsias and emesis occurring either as accompanying symptoms of gynaecological operations or as independent clinical conditions, therapeutic means for controlling these conditions and the mechanism of action and clinical usefulness of the dopamine antagonist domperidone have been discussed. The observations with this drug in 68 women suffering from dyspepsia and in 94 cases of emesis of different etiology have been analysed. The author stated that Motilium is the drug of choice in the treatment of complaints due to motility disorder of the upper gastroduodenal tract, that the patients tolerate the drug well, and that it's use does not hinder the treatment of the primary gynaecological disease, pre-operative therapy, anaesthesia, and postoperative care of the patients. Its antiemetic effect depends on the time of intake which is a disadvantage of oral application.
Divalproex in the treatment of migraine. [2013]Valproic acid has been used in the treatment of migraine headache for nearly 20 years. During this period of use several additional delivery modes have been developed to either improve tolerability or patient compliance with the divalproex sodium formulation and the extended-release formulation of divalproex sodium. Additionally, an intravenous formulation has become available which permits rapid achievement of therapeutic levels of the drug. There have been a number of reports on the use of valproic acid in migraine and other headache disorders, suggesting it to be an efficacious treatment. This paper reviews the results of the published reports of valproic acid in migraine and other headache disorders, including open-label studies, comparator trials, and double-blind, placebo-controlled trials. These studies have been conducted with the various formulations of valproic acid that have been on the market. The papers utilized in this study were obtained though Medline searches on valproic acid and divalproex sodium coupled with the various headache disorders. Additionally, the CD-ROM of past issues of Headache and Cephalalgia was reviewed for similar keywords. Lastly, the indices of the journal Headache Quarterly were reviewed for additional articles on valproic acid and divalproex sodium. Valproic acid in its various formulations has been demonstrated to be an efficacious and well-tolerated agent for the preventive treatment of migraine, chronic daily headache, and cluster headache. Additionally, it has been demonstrated to be efficacious and well tolerated in treating acute migraine attacks when given as an intravenous solution.
Use of meropenem to treat valproic acid overdose. [2020]Overdose of valproic acid (VPA) or its derivatives can cause significant toxicities such as hyperammonemia or altered mental status. While levocarnitine has been used historically to manage VPA-associated hyperammonemia, no standard of therapy exists to manage VPA toxicity. We present a case of VPA overdose managed with meropenem in addition to levocarnitine. A 38-year old female presented to the emergency department after intentionally ingesting 20 tablets of extended release divalproex sodium. She received a 4-gram loading dose of levocarnitine. She developed altered mental status, and a repeat VPA level yielded a result of 278 μg/mL. She was given 1 g of meropenem and her subsequent VPA level was 193 μg/mL. Approximately 8 h after the initial dose, another 1 g of meropenem was administered. Additionally, she received 1 g of levocarnitine every 4 h for a total of six doses. A repeat VPA level returned at 62 μg/mL. The patient was transferred to the intensive care unit for further management. Carbapenem antibiotics inhibit acylpeptide hydrolase in the gastrointestinal tract. Inhibition of this enzyme prevents the reabsorption of metabolized VPA and therefore causes increased elimination. Our patient demonstrated a rapid lowering of VPA levels after administration of meropenem.
Unusual drug reaction between valproate sodium and meropenem. [2021]We describe here a rare case in which valproic acid (VPA) levels were affected by ertapenem but not by meropenem even though ertapenem and meropenem are in the same carbapenem class. A 68-year-old Filipino male treated with valproate for epilepsy and ertapenem for an infectious disease had decreased VPA levels during the first day of ertapenem therapy. His VPA level increased soon after terminating ertapenem therapy. Two types of carbapenems had different drug reactions with concomitant use of VPA in this patient.
Gait instability in valproate-treated patients: Call to measure ammonia levels. [2018]Hyperammonemia induced by valproate (VPA) treatment may lead to several neurological and systemic symptoms as well as to seizure exacerbation. Gait instability and recurrent falls are rarely mentioned as symptoms, especially not as predominant ones.
Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. [2013]To compare the efficacy and safety of botulinum toxin type A (BoNTA; BOTOX: Allergan, Inc.) and divalproex sodium (DVPX; DEPAKOTE: Abbott Laboratories) as prophylaxis in reducing disability and impact associated with migraine.