Domperidone for Gastrointestinal Disorders

Overseen By Mehnaz Shafi

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antiarrhythmics, MAO inhibitors

Disqualifiers: Cardiac diagnoses, Liver failure, Electrolyte disorders, GI hemorrhage, Prolactinoma, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain heart medications or MAO inhibitors. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug domperidone for gastrointestinal disorders?

Research shows that domperidone is effective in treating nausea, vomiting, and dyspepsia (indigestion), especially after surgery. It works well for gastrointestinal motility disorders, helping the stomach and intestines move food more effectively. ^{1 2 3 4 5}

Is domperidone safe for human use?

Research indicates that domperidone is generally well-tolerated and does not have toxic effects, even when used in various conditions like postoperative nausea, dyspeptic complaints, and during acute myocardial infarction care. ^{1 3 4 6 7}

What makes the drug domperidone unique for treating gastrointestinal disorders?

Domperidone is unique because it acts as a peripheral dopamine2-receptor antagonist, which means it helps improve stomach and bowel movement without affecting the brain, reducing nausea and vomiting. Unlike some other treatments, it is well-tolerated and does not interfere with other medications or treatments, making it a preferred choice for managing gastrointestinal motility disorders. ^{3 4 6 7 8}

What is the purpose of this trial?

This trial studies how well domperidone works in treating patients aged 16 and older with gastrointestinal disorders. Domperidone helps the stomach move food more effectively by making its muscles contract. This can reduce symptoms like pain, bloating, nausea, and vomiting.

Research Team

Mehnaz Shafi

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with chronic gastrointestinal disorders like gastroparesis, severe heartburn, or indigestion that haven't improved with standard treatments. They must have stable blood counts and organ function, no other causes for their symptoms after a full check-up, and agree to the study's terms. It's not open to pregnant women, those on certain heart drugs or MAO inhibitors, people allergic to domperidone, or anyone with specific heart conditions or severe liver issues.

Inclusion Criteria

I have agreed to take the study drug, domperidone, by signing a consent form.

Your hemoglobin level is at least 8.0 grams per deciliter and not changing.

I have severe stomach issues like gastroparesis, GERD, or dyspepsia.

Exclusion Criteria

I am taking medication that affects my heart's rhythm.

I have a history of or currently have liver failure.

I am not pregnant or breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive domperidone orally thrice daily or four times daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Domperidone

Trial Overview The trial is testing how effective domperidone is in treating chronic gastrointestinal disorders by seeing if it can help control symptoms such as pain, bloating, nausea and vomiting. This involves taking the medication and completing questionnaires about symptom changes.

Participant Groups

Group I: Treatment (domperidone) Experimental Treatment 2 Interventions

Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

A randomized, double-blind, placebo-controlled trial involving 208 patients with functional dyspepsia showed that combining compound azintamid with domperidone significantly improved symptoms compared to domperidone alone, with a response rate of 89.2% in the combination group versus 76.4% in the control group.

The combination therapy led to greater reductions in bloating and pain intensity, as well as improved patient satisfaction, without any severe side effects, suggesting it is a safe and effective treatment option for functional dyspepsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combination therapy of azintamid and domperidone in functional dyspepsia: a randomised, double-blind, placebo-controlled trial]. Zhao, L., Xu, L., Li, Q., et al.[2014]

Domperidone is effective in relieving symptoms of gastrointestinal motility disorders, particularly diabetic gastroparesis, showing better symptom relief than placebo and similar efficacy to other prokinetic drugs like metoclopramide and cisapride.

With minimal central nervous system penetration, domperidone has a favorable safety profile, making it a safer alternative to metoclopramide, with rare reports of adverse effects such as dystonic reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone: a peripherally acting dopamine2-receptor antagonist. Barone, JA.[2017]

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]

A significant number of patients (69.7%) receiving domperidone were also prescribed QT-interacting medications, which can increase the risk of life-threatening arrhythmias due to QT prolongation.

Inconsistent EKG monitoring was observed, with 15.3% of patients showing QT prolongation at the start of treatment and 32.5% at follow-up, highlighting the need for better monitoring to prevent cardiac risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone is Commonly Prescribed With QT-Interacting Drugs: Review of a Community-based Practice and a Postmarketing Adverse Drug Event Reporting Database. Ehrenpreis, ED., Roginsky, G., Alexoff, A., et al.[2019]

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]

In a study of 73 gynecological patients, domperidone effectively controlled various dyspeptic symptoms, nausea, vomiting, climacteric flushes, and migraine prevention in 67.1% of cases.

The drug showed a significant gastrokinetic and antiemetic effect, suggesting it can be used alone or alongside other treatments for migraines and climacteric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some possible gynaecological indications for peripheral antidopamine therapy. Varga, A., Lovas, J.[2013]

In a study of 100 children aged 5-12 with abdominal pain predominant functional gastrointestinal disorders, those treated with domperidone showed a significant improvement in symptoms compared to the placebo group, with 74% reporting general improvement after 8 weeks.

Domperidone also led to a notable reduction in abdominal pain severity and an increase in gastric motility, with no reported adverse effects, suggesting it is a safe and effective treatment option for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Clinical Trial on Value of Domperidone in Functional Abdominal Pain in Children. Karunanayake, A., Devanarayana, NM., de Silva, A., et al.[2019]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

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

2. China pubmed.ncbi.nlm.nih.gov

[Combination therapy of azintamid and domperidone in functional dyspepsia: a randomised, double-blind, placebo-controlled trial]. [2014]

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

Domperidone: a peripherally acting dopamine2-receptor antagonist. [2017]

4. 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]

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

Domperidone is Commonly Prescribed With QT-Interacting Drugs: Review of a Community-based Practice and a Postmarketing Adverse Drug Event Reporting Database. [2019]

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

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

7. Hungary pubmed.ncbi.nlm.nih.gov

Some possible gynaecological indications for peripheral antidopamine therapy. [2013]

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

Randomized Controlled Clinical Trial on Value of Domperidone in Functional Abdominal Pain in Children. [2019]