Domperidone for Gastroparesis and Acid Reflux

Overseen By Corey Schurman, MA, CCRC

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Arrhythmias, Bradycardia, Electrolyte disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 12 months

20 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

What makes the drug Domperidone unique for treating gastroparesis and acid reflux?

Domperidone is unique because it works by increasing the movement of the stomach and intestines, which helps to speed up the passage of food through the stomach, making it particularly effective for conditions like gastroparesis and acid reflux where delayed gastric emptying is a problem. ^{6 7 8 9 10}

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. ^{1 2 3 4 11}

Who Is on the Research Team?

Jose Cocjin, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Domperidone

Trial Overview Domperidone 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.

How Is the Trial Designed?

Group I: Overall Study Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

In a study involving 23 critically ill feed-intolerant patients, a single dose of 50 mg camicinal significantly accelerated gastric emptying and increased glucose absorption compared to placebo, indicating its potential efficacy as a gastric promotility agent.

The results showed a reduction in gastric emptying time from 121 minutes to 65 minutes post-treatment with camicinal, along with a notable increase in glucose absorption, suggesting that camicinal could improve nutritional delivery in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chapman, MJ., Deane, AM., O'Connor, SL., et al.[2018]

Domperidone is an effective treatment for gastroparesis, showing superior efficacy compared to placebo and other available therapies, despite its controversial status in the US due to safety concerns.

Although there are safety concerns regarding cardiac toxicity associated with domperidone, the evidence on this issue is not convincing, suggesting that its benefits may outweigh the risks for patients with gastrointestinal motility disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making a case for domperidone in the treatment of gastrointestinal motility disorders. Ahmad, N., Keith-Ferris, J., Gooden, E., et al.[2013]

In a study involving 57 patients recovering from acute myocardial infarction, domperidone (Motilium) effectively prevented nausea, vomiting, and gastroduodenal complaints during the recovery period.

Domperidone was found to promote bowel movement and defecation without causing cardiac or other toxic effects, making it a safe option for patients in intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of domperidone in improving intestinal activity in acute myocardial infarction patients. Lencz, L.[2013]

Domperidone (Motilium) is as effective as other well-known anti-emetics like Daedalon (Dramamin) and Torecan in preventing nausea and vomiting after surgery, based on a comparative study.

Domperidone is particularly advantageous due to its oral administration route and lack of toxic effects, making it a favorable option for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of domperidone (Motilium) in controlling postoperative nausea and vomiting. Lencz, L.[2013]

In a study of 17 patients with gastroparesis, chronic treatment with domperidone significantly reduced gastrointestinal symptoms and hospital admissions, improving overall quality of life for 88% of participants.

Domperidone also accelerated gastric emptying, with solid meal retention improving from 87.3% at baseline to 57.2% during treatment, indicating its efficacy in managing gastroparesis over an average treatment duration of 23.3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chronic oral domperidone therapy on gastrointestinal symptoms, gastric emptying, and quality of life in patients with gastroparesis. Soykan, I., Sarosiek, I., McCallum, RW.[2016]

Domperidone (Motilium) is effective in treating dyspepsia and emesis in women, with a study involving 68 women with dyspepsia and 94 cases of emesis showing good tolerance and no interference with gynaecological treatments.

The drug's antiemetic effect is influenced by the timing of intake, which can be a limitation for oral administration, but it remains a preferred option for managing upper gastroduodenal motility disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of peripheral dopamine antagonist (Motilium) in the treatment of dyspeptic complaints of different origin and in nausea, vomiting. Sásdi, A.[2013]

Valproic acid has been shown to be an effective and well-tolerated treatment for preventing migraines, chronic daily headaches, and cluster headaches, based on a review of various studies including open-label and double-blind trials.

The introduction of an intravenous formulation allows for rapid achievement of therapeutic levels, making it effective for treating acute migraine attacks as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Divalproex in the treatment of migraine. Freitag, FG.[2013]

In a case of valproic acid overdose, a combination of levocarnitine and meropenem was used, resulting in a significant reduction of valproic acid levels from 278 μg/mL to 62 μg/mL, demonstrating the potential efficacy of this treatment approach.

Meropenem works by inhibiting acylpeptide hydrolase in the gastrointestinal tract, which prevents the reabsorption of metabolized valproic acid, thus enhancing its elimination from the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of meropenem to treat valproic acid overdose. Dreucean, D., Beres, K., McNierney-Moore, A., et al.[2020]

In a rare case involving a 68-year-old male patient, the use of ertapenem significantly decreased valproic acid (VPA) levels, while meropenem did not affect VPA levels, highlighting a unique interaction between different carbapenems and VPA.

This case suggests that patients on VPA who are prescribed carbapenems like ertapenem should have their VPA levels closely monitored, and alternative anti-epileptic medications may be considered to avoid potential drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unusual drug reaction between valproate sodium and meropenem. Yoon, H., Kim, DH.[2021]

In a study of five adult patients with frontal lobe epilepsy treated with valproate (VPA), gait instability and falls were identified as significant adverse effects, likely due to hyperammonemia, despite VPA levels being within the normal range.

Reducing or stopping the VPA treatment led to normalization of ammonia levels and resolution of symptoms, including seizures, highlighting the importance of monitoring ammonia levels in patients on VPA therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait instability in valproate-treated patients: Call to measure ammonia levels. Kipervasser, S., Elger, CE., Korczyn, AD., et al.[2018]

In a study of 59 patients, both botulinum toxin type A (BoNTA) and divalproex sodium (DVPX) effectively reduced migraine-related disability and headache frequency, showing significant improvements in migraine disability scores.

BoNTA was better tolerated than DVPX, with fewer patients experiencing adverse events (50% for BoNTA vs. 75.8% for DVPX) and a much lower discontinuation rate due to side effects (3.3% for BoNTA vs. 27.6% for DVPX).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. Blumenfeld, AM., Schim, JD., Chippendale, TJ.[2013]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Making a case for domperidone in the treatment of gastrointestinal motility disorders. [2013]

3. Hungary pubmed.ncbi.nlm.nih.gov

Role of domperidone in improving intestinal activity in acute myocardial infarction patients. [2013]

4. Hungary pubmed.ncbi.nlm.nih.gov

The importance of domperidone (Motilium) in controlling postoperative nausea and vomiting. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of chronic oral domperidone therapy on gastrointestinal symptoms, gastric emptying, and quality of life in patients with gastroparesis. [2016]

6. Hungary pubmed.ncbi.nlm.nih.gov

Use of peripheral dopamine antagonist (Motilium) in the treatment of dyspeptic complaints of different origin and in nausea, vomiting. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Divalproex in the treatment of migraine. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Use of meropenem to treat valproic acid overdose. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Unusual drug reaction between valproate sodium and meropenem. [2021]

10. Denmark pubmed.ncbi.nlm.nih.gov

Gait instability in valproate-treated patients: Call to measure ammonia levels. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. [2013]